BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC READER

    MDR report key: 2003322 · Received March 1, 2011

    Report

    Report Number
    1823260-2011-01067
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 19, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K000784
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE CARDIAC READER INSTRUMENT NOR THE STRIPS WERE RETURNED FOR INVESTIGATION. THE INVESTIGATION WAS PERFORMED USING RETENTION MATERIAL WITH NO MALFUCTION DETECTED. THE LOW TROPONIN T RESULT MAY HAVE BEEN CAUSED BY THE SAMPLE'S LOW HEMATOCRIT. NO DETAILED PATIENT INFORMATION WAS PROVIDED. FURTHER TESTING WOULD BE RECOMMENDED. IF THE CLINIAL CIRCUMSTANCE SUGGESTED AN ISCHEMIC MECHANISM WAS UNLIKELY, OTHER CAUSES OF CHEST PAIN SHOULD BE CONSIDERED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TROPONIN T QUANTITATIVE (TNT) RESULTS FOR ONE EMERGENCY ROOM PATIENT WHEN TESTED USING THE CARDIAC READER. THE INITIAL TNT RESULT WAS <0.1 NG/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED ON A COBAS 6000 E601 ANALYZER (SERIAL NUMBER (B)(4)) AND RECOVERED 0.161 NG/ML. BOTH RESULTS RESULTS WERE REPORTED OUTSIDE THE LABORATORY TO THE EMERGENCY ROOM. THE CUSTOMER STATED THE EMERGENCY ROOM DID NOT QUESTION THE RESULTS. THE CARDIAC READER RESULT WAS CONSIDERED ERRONEOUS BY THE CUSTOMER. THE COBAS E601 TNT RESULT MATCHED THE PATIENT'S PREVIOUS TNT RESULT FROM (B)(6). NO ADVERSE EVENTS WERE REPORTED. THE PATIENT HAS BEEN DISCHARGED. THE CARDIAC TNT TEST STRIP LOT NUMBER WAS 22670940. THE CUSTOMER DECLINED TO RETURN THE CARDIAC READER AND DECLINED SERVICE. SHE BELIEVED THERE WAS AN ISSUE WITH THE PATIENT SAMPLE SINCE THE HEMATOCRIT OF THE SAMPLE WAS 9% AND THE ACCOUNT HAS NOT HAD PROBLEMS WITH ANY OTHER SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC READER CARDIAC READER SYSTEM MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR