BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 6118142 · Received November 21, 2016

    Report

    Report Number
    2027969-2016-00685
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K042890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 W61021. NO ISSUES WITH D-DIMER RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W61021 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 THE TRIAGE D-DIMER WAS SHOWING A LOW VALUE AT THE NORMAL CONTROL. EVENT OCCURRED IN (B)(6). CUSTOMER REPORTED DURING A TEST USING THE D-DIMER PANEL THE RESULTS WERE SHOWING A LOW VALUE RESULT OF THE NORMAL CONTROL. COMPLAINANT PERFORMED COMPARATIVE TESTS WITH PATIENTS AND HAD LOW RESULTS. (B)(6). NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THE CUSTOMER HAD DISCARDED THE PRODUCT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767980 TRIAGE D-DIMER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 98100EU W61021RB

    Patients

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