MAUDE Adverse Event Report | 合法醫療器材資訊網
Theinitialreportercomplainedofdiscrepantlowresultsfor1patientsampletestedforelecsysmyoglobin(myoglobin)onacobase801module.Theinitialresult ...
The initial reporter complained of discrepant low results for 1 patient sample tested for elecsys myoglobin (myoglobin) on a cobas e801 module.The initial result was 2042 ug/l.The sample was repeated twice with results of 1880 ug/l and 1753 ug/l.On (b)(6) 2020 the customer repeated the sample using a 1:50 dilution and a 1:100 dilution with results of >150,000 ug/l and 272,737 ug/l respectively.The result of 272,737 ug/l was reported outside of the laboratory.Previous samples from the patient had very high myoglobin results (330,000 ug/l and 195,000 ug/l).No questionable low results were reported outside of the laboratory.The e801 module serial number was (b)(4).
Section d4: expiration date was updated.The investigation determined the event was due an issue with the p...
Elecsys Myoglobin | 合法醫療器材資訊網
Elecsys Myoglobin Calibrator | 合法醫療器材資訊網
Establishment Registration & Device Listing | 合法醫療器材資訊網
K083260 ELECSYS MYOGLOBIN STAT | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
REVIEW MEMORANDUM | 合法醫療器材資訊網
羅氏免疫分析肌紅蛋白檢驗試劑Elecsys Myoglobin} | 合法醫療器材資訊網
【羅氏免疫分析肌紅蛋白檢驗試劑】許可證字號:衛部醫器輸字第025251號
器材品名:羅氏免疫分析肌紅蛋白檢驗試劑許可證字號:衛部醫器輸字第025251號註銷狀態:註銷日期:註銷理由:有效日期:2023/08/01...
【羅氏免疫分析肌紅蛋白檢測試劑】許可證字號:衛部醫器輸字第030089號
器材品名:羅氏免疫分析肌紅蛋白檢測試劑許可證字號:衛部醫器輸字第030089號註銷狀態:註銷日期:註銷理由:有效日期:2022/10/30...