BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 6135711 · Received November 30, 2016

    Report

    Report Number
    2027969-2016-00697
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62034. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62034 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR TESTING. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT RESULTS FOR TROPONIN I AT A PATIENT CLINIC. EVENT OCCURRED IN (B)(6). PATIENT # 2 BELOW HAD A POSITIVE RESULT FOR TROPONIN I, BUT THE FOLLOW WAS A NEGATIVE RESULT. ON (B)(6) 2016 08:07 RESULT: 0.7 CPK:120 CKMB: 13. ON (B)(6) 2016 21:40 RESULT: <0.05 CPK:102 CKMB: 10. ECG NORMAL PARAMETERS. OPTIC CHECK OK . NO REPORTED ADVERSE PATIENT SEQUELA. THIS DISCORDANT RESULTS ONLY APPEAR FOR TROPONIN I. THE OTHER CARDIAC ENZYMES RESULTS WERE COHERENT WITH PATIENT CLINIC. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787318 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HSEU W62034RB

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO SERIAL #(B)(4)