平成30年 1月25日作成
平成31年 1月24日訂正(*)

一般的名称： 汎用血液ガス分析装置
販売名　　： ABL800 FLEX システム

　　対象：全802台*
出荷時期：平成17年3月17日〜平成29年12月28日
製造番号：
754R0007N010,754R0010N003,754R0042N001,754R0042N006,754R0065N005,754R0066N008,
754R0066N009,754R0069N003,754R0072N005,754R0074N004,754R0084N004,754R0084N006,
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754R1450N002,754R1456N006,754R1457N002,754R1457N004,754R1457N006,754R1458N006,
754R1458N007,754R1459N002,754R1461N005,754R1463N001,754R1463N002,754R1465N007,
754R1467N006,754R1469N008,754R1471N001,754R1471N003,754R1472N002,754R1472N004,
754R1472N007,754R1489N006,754R1490N001,754R1490N005,754R1490N006,754R1490N007,
754R1493N002,754R1493N003,754R1493N005,754R1494N007,754R1497N002,754R1497N004,
754R1498N001,754R1498N002,754R1498N003,754R1498N004,754R1499N005,754R1508N002,
754R1508N003,754R1522N002,754R1522N004,754R1522N005,754R1523N002,754R1523N003,
754R1523N004,754R1523N005,754R1524N002,754R1524N003,754R1524N008,754R1525N007,
754R1525N008,754R1526N005,754R1527N002,754R1527N003,754R1527N008,754R1528N002,
754R1529N005,754R1531N001,754R1533N001,754R1533N003,754R1534N001,754R1536N004,
754R1538N001,754R1538N002,754R1538N003,754R1538N004,754R1543N005,754R1543N006,
754R1545N006,754R1546N002,754R1546N004,754R1546N005,754R1553N003,754R1556N001,
754R1556N005,754R1556N007,754R1558N004,754R1558N005,754R1563N007,754R1569N001,
754R1569N002,754R1572N001,754R1572N002,754R1572N003,754R1572N007,754R1574N001,
754R1574N003,754R1574N004,754R1575N001,754R1579N004,754R1586N006,754R1588N004,
754R1589N003,754R1590N003,754R1590N004,754R1594N002,754R1599N005,754R1600N001,
754R1601N005,754R1601N006,754R1602N001,754R1603N001,754R1603N002,754R1608N004,
754R1613N003,754R1613N004,754R1614N002,754R1615N002,754R1622N001,754R1622N003,
754R1622N004,754R1624N001,754R1639N007,754R1639N008,754R1644N005,754R1644N006,
754R1649N006,754R1657N005,754R1657N008,754R1660N004,754R1660N005,754R1660N007,
754R1661N001,754R1665N005,754R1670N006,754R1670N008,754R1671N004,754R1671N007,
754R1671N008,754R1685N006,754R1685N008,754R1687N007,754R1691N002,754R1691N005,
754R1691N006,754R1691N007,754R1696N007,754R1698N003,754R1707N005,754R1707N006,
754R1707N007,754R1707N009,754R1708N001,754R1708N003,754R1726N004,754R1730N003,
754R1730N004,754R1731N003,754R1731N004,754R1731N005,754R1731N007,754R1732N004,
754R1732N005,754R1736N003,754R1736N004,754R1736N005,754R1736N006,754R1736N007,
754R1737N004,754R1737N005,754R1737N006,754R1741N006,754R1741N007,754R1742N002,
754R1742N003,754R1742N006,754R1742N007,754R1743N001,754R1743N002,754R1746N006,
754R1746N007,754R1747N001,754R1747N003,754R1747N006,754R1751N004,754R1751N005,
754R1751N006,754R1754N002,754R1754N003,754R1754N005,754R1754N007,754R1755N004,
754R1755N006,754R1755N007,754R1755N008,754R1758N002,754R1761N002,754R1761N005,
754R1762N001,754R1762N003,754R1763N001,754R1763N004,754R1768N004,754R1768N006,
754R1779N004,754R1779N005,754R1780N001,754R1780N005,754R1804N006,754R1805N001,
754R1807N003,754R1807N004,754R1807N005,754R1828N007,754R1829N009,754R1856N002,
754R1858N006,754R1859N005,754R1859N008,754R1865N001,754R1865N002,754R1865N005,
754R1868N001,754R1868N002,754R1868N003,754R1869N002,754R1869N003,754R1869N006,
754R1869N008,754R1870N002,754R1870N007,754R1871N002,754R1871N003,754R1872N002,
754R1872N003,754R1872N006,754R1872N008,754R1874N003,754R1874N004,754R1874N005,
754R1877N001,754R1881N002,754R1881N007,754R1881N008,754R1888N006,754R1888N007,
754R1889N002,754R1890N003,754R1890N004,754R1894N005,754R1894N006,754R1903N001,
754R1903N003,754R1903N007,754R1906N006,754R1906N007,754R1907N005,754R1907N007,
754R1907N008,754R1908N002,754R1908N007,754R1915N007,754R1916N001,754R1916N004,
754R1942N003,754R1942N004,754R1942N005,754R1942N006,754R1946N004,754R1948N003,
754R1948N004,754R1953N001,754R1959N005,754R1961N001,754R1962N001,754R1962N004,
754R1974N005,754R1975N003,754R1978N001,754R1978N002,754R1978N003,754R1981N004,
754R1982N002,754R1982N004,754R1982N005,754R1985N001,754R1990N006,754R1990N007,
754R1999N001,754R2019N006,754R2024N005,754R2026N003,754R2026N004,754R2028N001,
754R2028N003,754R2031N002,754R2032N005,754R2034N005,754R2034N007,754R2034N008,
754R2040N005,754R2040N006,754R2041N001,754R2041N003,754R2041N004,754R2041N007,
754R2049N001,754R2054N001,754R2054N007,754R2058N007,754R2059N002,754R2059N006,
754R2060N002,754R2062N006,754R2062N007,754R2073N002,754R2073N003,754R2084N001,
754R2084N002,754R2087N001,754R2087N004,754R2089N003,754R2090N001,754R2099N005,
754R2100N002,754R2104N002,754R2104N006,754R2105N003,754R2106N001,754R2122N004,
754R2122N007,754R2123N001,754R2123N002,754R2131N004,754R2145N004,754R2147N003,
754R2153N001,754R2153N002,754R2153N004,754R2153N006,754R2153N007,754R2155N001,
754R2155N005,754R2174N006,754R2175N002,754R2185N006,754R2186N001,754R2186N002,
754R2186N003,754R2194N007,754R2213N004,754R2213N005,754R2213N006,754R2215N003,
754R2240N001,754R2250N003,754R2259N001,754R2260N004,754R2260N005,754R2261N003,
754R2261N006,754R2266N006,754R2266N007,754R2269N004,754R2270N002,754R2270N003,
754R2270N004,754R2270N005,754R2281N002,754R2284N001,754R2285N005,754R2285N006,
754R2286N006,754R2289N002,754R2303N001,754R2311N002,754R2312N002,754R2312N004,
754R2313N001,754R2313N003,754R2313N004,754R2317N003,754R2317N004,754R2318N001,
754R2318N002,754R2328N007,754R2335N005,754R2340N003,754R2342N005,754R2343N004,
754R2346N002,754R2346N003,754R2346N004,754R2362N007,754R2364N001,754R2364N004,
754R2364N006,754R2407N003,754R2409N001,754R2409N005,754R2409N011,754R2409N012,
754R2410N003,754R2411N003,754R2411N006,754R2414N002,754R2415N002,754R2428N002,
754R2428N004,754R2429N010,754R2443N006,754R2444N004,754R2444N010,754R2445N001,
754R2452N002,754R2452N003,754R2461N006,754R2461N007,754R2461N008,754R2461N011,
754R2461N016,754R2461N017,754R2462N009,754R2462N012,754R2472N005,754R2472N006,
754R2474N001,754R2477N002,754R2477N004,754R2484N002,754R2488N001,754R2492N007,

製造販売業者の名称　： ラジオメーター株式会社
製造販売業者の所在地： 東京都品川区北品川4丁目7番35号
許可の種類　　　　　： 第二種医療機器製造販売業
許可番号　　　　　　： 13B2X00079
輸入元製造業者：RADIOMETER MEDICAL ApS　(デンマーク国)

海外製造元より、当該医療機器のオプションであるFLEXQモジュールを搭載している場合、測定前に事前の
サンプル登録を行った際、個別識別番号をサンプルへ付与し、「FLEXQ登録受領バーコード」を印刷することがで
きますが、当該サンプル測定終了後、装置で「FLEXQ登録受領バーコード」を使用し患者測定結果を呼び出した際
に、バーコード情報を誤読し、他の患者測定結果を呼び出してしまう可能性があるとの報告を受けました。製造
元での検証の結果、誤読が生じる可能性は極めて稀であるとのことです。また、他の患者情報を呼び出した場
合、作業者は画面表示により異なる患者情報を表示していることに気づくことができます。当該事象に関しまし
て、昨年より情報提供を開始し、該当する施設に対し既に注意喚起を実施しております。
このたび、機器の制御プログラムの変更により、本事象が発生しないよう制御プログラムの変更を実施します。

本不具合が発生した場合、ごく稀に患者情報の誤認識が発生する可能性があります。しかしながら、作業者は読
み込みに使用したプリントアウトの患者情報と画面上に表示される患者情報から容易に異なる患者情報を表示し
ていることに気づくことができます。また、患者の診断治療はさまざまな臨床上の情報を総合的に判断して行わ
れるものであり、本品の測定値のみで医療処置が行われるものではありませんので、該当の事象による重篤な健
康被害の発生はないものと考えております。
尚、現在までのところ日本国内において患者健康被害の報告はございません。

平成30年1月25日

血液中のpH、pCO2、pO2、tHb、sO2、COHb、MetHb、HHb、O2Hb、HbF、カリウム、ナトリウム、カルシウム、
クロール、グルコース、ラクテート、Creaの各濃度を測定し、酸塩基平衡や酸素化状態に関する
演算パラメーターを必要に応じて印字する自動測定装置。

該当製品の納入先は特定しておりますので、納入しました代理店及び医療機関に対して自主改修を行う旨を通知
し、自主改修を行います。

担当者　： 品質保証・薬事統括*
　　　　　 鈴木香織*
連絡先　： ラジオメーター株式会社
　　　　　 東京都品川区北品川区４丁目７番３５号
電話番号： 03-6311-7204
FAX番号 ： 03-3764-0577