BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPONIN I STAT (SHORT TURN AROUND TIME)

    MDR report key: 3853653 · Received June 6, 2014

    Report

    Report Number
    1823260-2014-04121
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K082699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH CONTINUED INVESTIGATIONS, IT WAS DETERMINED THAT THE PROVIDED PATIENT SAMPLE ONLY HAD FALSE POSITIVE RESULTS WITH REAGENT LOT 175765. ALL OTHER LOTS TESTED RESULTED CORRECTLY AS NEGATIVE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN I STAT (SHORT TURN AROUND TIME) ON A COBAS E411 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 1.44 NG/ML ACCOMPANIED BY A DATA FLAG, WHICH IS CONSIDERED POSITIVE. THE SAMPLE WAS REPEATED AND RESULTED AS 1.46 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2014 WITH A DIFFERENT REAGENT PACK AND RESULTED AS 1.38 NG/ML ACCOMPANIED BY A DATA FLAG. ONE OF THE ERRONEOUS RESULTS WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A CHECK UP AND WAS TESTED FOR TROPONIN I USING THE PATHFAST METHOD. THE PATHFAST RESULT WAS NEGATIVE. THE SAMPLE WAS SENT TO ANOTHER FACILITY FOR REPEAT TESTING ON A DIFFERENT E411 ANALYZER. AT THE OTHER SITE, THE SAMPLE WAS TESTED ON (B)(6) 2014 AND RESULTED AS 1.41 NG/ML ACCOMPANIED BY A DATA FLAG WITH TROPONIN I STAT REAGENT LOT NUMBER 175765. THE SAMPLE WAS REPEATED A SECOND TIME AT THE OTHER SITE WITH A 1:2 DILUTION AND RESULTED AS 0.924 NG/ML ACCOMPANIED BY A DATA FLAG WITH TROPONIN I STAT REAGENT LOT NUMBER 175765. THE SAMPLE WAS REPEATED A THIRD TIME AT THE OTHER SITE ON (B)(6) 2014 AND RESULTED AS 0.100 NG/ML ACCOMPANIED BY A DATA FLAG WITH TROPONIN I STAT REAGENT LOT NUMBER 174423. THE 0.100 NG/ML VALUE WAS CONSIDERED TO BE NEGATIVE. THE SAMPLE WAS REPEATED A FOURTH TIME AT THE OTHER SITE WITH A 1:2 DILUTION AND RESULTED AS 0.100 NG/ML ACCOMPANIED BY A DATA FLAG WITH TROPONIN I STAT REAGENT LOT NUMBER 174423. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE COBAS E411 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED. THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. PRELIMINARY INVESTIGATIONS HAVE DETERMINED THAT THE CUSTOMER'S RESULTS COULD BE REPRODUCED. WHEN USING RETENTION KITS OF TROPONIN I STAT REAGENT LOT 175765 AND REAGENT LOT 174423, THE RESULTS ARE CLEARLY DISCREPANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332958 TROPONIN I STAT (SHORT TURN AROUND TIME) IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS NA 175765

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR DIABETES MEDICINE