BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, TRIAGE, CARDIAC TNI / CKMB

    MDR report key: 5377612 · Received January 19, 2016

    Report

    Report Number
    2027969-2016-00032
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    May 28, 2015
    Report Date
    January 5, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE (CONTINUED): DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING HISTORY FOR THE LOT WAS PERFORMED AND THE RESULTS WERE WITHIN FINAL RELEASE SPECIFICATIONS. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER DID NOT RETURN A SAMPLE; THEREFORE SAMPLE SPECIFIC INTERFERENCE IS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. THE ROOT CAUSE FOR THE ALLEGED DISCREPANT LOW TROPONIN COMPLAINT COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A VARIANCE BETWEEN THE TRIAGE TROPONIN (TNI) RESULT IN COMPARISON TO THE BECKMAN DXI 800 LABORATORY ANALYZER. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, TRIAGE TNI: <0.05, LABORATORY TNI: 0.18. THE TRIAGE TNI WAS WITHIN THE CUSTOMERS ASSIGNED "NORMAL" RESULT RANGE AND THE LABORATORY TNI WAS IN AN "INDETERMINATE" RESULT RANGE. THERE WERE NO REPORTED ADVERSE EVENTS RELATED TO THE TRIAGE RESULT AND NO PATIENT SPECIFIC INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35152 KIT, TRIAGE, CARDIAC TNI / CKMB CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97022HS W59490RB

    Patients

    Seq Age Sex Outcome Treatment
    1