BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT,TRIAGE, CARDIAC TNI / CKMB

    MDR report key: 4950431 · Received July 29, 2015

    Report

    Report Number
    2027969-2015-00545
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D2B PROCODE (CONTINUED): DDR, JHX, MMI. INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE PRODUCT DID NOT RETURN FOR INVESTIGATION. SINCE NO PRODUCT WAS RETURNED, IN HOUSE TESTING WAS PERFORMED WITH RETAIN DEVICES. THERE WERE NO DISCREPANT HIGH CKMB RESULTS OBSERVED ON RETAINED DEVICE TESTED WITH 10 NORMAL WHOLE BLOOD DONOR SAMPLES. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR CARDIAC LOT W59492RB WAS PERFORMED. THERE WERE NO ISSUES WITH CKMB RECOVERY OBSERVED AND THE LOT PASSED ALL FINAL RELEASE SPECIFICATIONS. TWO (2) PATIENT BLOOD SAMPLES WERE RETURNED FOR TESTING. THE SAMPLES WERE FROM THE SAME PATIENT BUT AT DIFFERENT COLLECTION TIMES. THE CUSTOMER'S COMPLAINT WAS REPLICATED WITH RETURNED PATIENT SAMPLES (ELEVATED CKMB FROM RETURNED SAMPLES ON COMPLAINT LOT). HUMAN ANTI-MOUSE ANTIBODIES (HAMA) INTERFERENCE TESTING WAS CONDUCTED ON THE RETURNED SAMPLE. THE RETURNED SAMPLE CKMB RESULT DECREASED MORE THAN 50% OF ORIGINAL RESULT; SAMPLE CONTAINED HAMA INTERFERENCE. THE ROOT CAUSE FOR THE DISCREPANT HIGH CKMB RESULTS WAS DUE TO THE SAMPLE CONTAINING HAMA INTERFERENCE. AS OF 08/05/2015, THIS IS THE ONLY DISCREPANT HIGH COMPLAINT AGAINST CARDIAC LOT W59492RB. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE (3) HIGH CK-MB RESULTS ON A PATIENT. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH BRADYCARDIA AND CHEST PAINS. RESULTS ARE AS FOLLOWS: DATE AND TIME: 07/06/2015 COLLECTED AT 20:00, TRIAGE CK-MB: >80NG/ML AND REPEAT >80NG/ML; DATE AND TIME: 07/07/2015 COLLECTED AT 03:00, TRIAGE CK-MB: 2.2NG/ML AND REPEATED AT 10:00 >80NG/ML; DATE AND TIME: COLLECTED AT 13:00, TRIAGE CK-MB: 1.2NG/ML. ALL TRIAGE TNI RESULTS WERE <0.05NG/ML AND NORMAL TOTAL CK RESULTS. THE TOTAL CK RESULTS ON THE COBAS INTEGRA 400 PLUS ANALYZER WAS 140 ON THE ORIGINAL BLOOD DRAW AND 125 ON THE SECOND BLOOD DRAWN BUT IT WAS HEMOLYZED. THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495077 KIT,TRIAGE, CARDIAC TNI / CKMB CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97022HS W59492RB

    Patients

    Seq Age Sex Outcome Treatment
    1