BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 6119121 · Received November 21, 2016

    Report

    Report Number
    2027969-2016-00686
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W62069. NO ISSUES WITH CKMB RECOVERY OBSERVED. REVIEWED THE BATCH RECORD FOR LOT W62069. LOT MET ALL OUS FINAL RELEASE SPECIFICATIONS. UNABLE TO DETERMINE ROOT CAUSE OF COMPLAINT. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). CUSTOMER ALLEGING TRIAGE PROFILER SOB PANEL HAD DISCREPANT RESULTS WITH CK-MB IN COMPARISON TO THE RESULTS FROM THE HOSPITAL LABORATORY. TRIAGE CK MB RESULT 33,3 ( SHOULD BE WITHIN 0-4,3) AND IN THE HOSPITAL AFTER VENOUS BLOOD SAMPLE IT WAS 17,6 AND IT SHOULD BE LESS THAN 24. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767483 TRIAGE PROFILER SOB PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97300EU W62069B

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR TRIAGE METERPRO INTERNATIONAL SERIAL #(B)(4)