BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. CITRATE APTT CUVETTE

    MDR report key: 3787201 · Received February 4, 2014

    Report

    Report Number
    2248721-2014-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    November 11, 2013
    Report Date
    January 7, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GFO
    PMA / PMN Number
    K014008
    Removal / Correction Number
    2250033-12/06/13-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. METHOD: CUVETTE/SINGLE-USE DISPOSABLE. AS PART OF ITC'S INVESTIGATION, EVALUATION TESTING WAS PERFORMED ON RETAIN SAMPLES OF A SIMILAR LOT. PROCESS EVALUATION PERFORMED. REVIEW AND TREND ANALYSIS OF FINISHED PRODUCT QC TEST DATA WAS PERFORMED. MANUFACTURING PROCESS REVIEWED. RESULT: AN UPWARD SHIFT IN NON-HEPARINIZED BLOOD RESPONSE WHEN COMPARED TO HISTORICAL PERFORMANCE WAS IDENTIFIED. CONCLUSION: MANUFACTURER NOTIFIED FDA ON DECEMBER 6, 2013 OF THE VOLUNTARY RECALL OF (B)(4) LOTS OF HEMOCHRON JR. CITRATE APTT CUVETTES. ITC'S INVESTIGATION INTO THE PRODUCT'S PERFORMANCE IDENTIFIED THAT THE AFFECTED LOTS OF J103C CUVETTES MAY RECOVER HIGHER THAN EXPECTED RESULTS IN NORMAL INDIVIDUALS. WHEN TESTING NON-HEPARINIZED (E.G. NORMAL BLOOD SAMPLES), RESULTS MAY AVERAGE HIGHER THAN HISTORIC VALUES. TEST RESULTS PERFORMED ON PATIENTS RECEIVING HEPARIN THERAPY ARE NOT AFFECTED. THE UPWARD SHIFT IN NON-HEPARINIZED BLOOD RESPONSE IS ASSOCIATED WITH A RECENT FORMULARY OPTIMIZATION. CORRECTION OF THE NORMAL RANGE SHIFT BEING IMPLEMENTED TO ASSURE THAT TEST RESULTS FROM NON-HEPARINIZED SAMPLED IN FUTURE LOT RELEASES WILL PERFORM SIMILAR TO HISTORIC EXPERIENCES.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS RESULTS HIGHER THAN REFERENCE LABORATORY WITH HEMOCHRON JR. CITRATED APTT CUVETTE ASSAY FOR PT WITH ADMITTING DIAGNOSIS OF ABDOMINAL PAIN AND CHOLECYSTITIS. HEMOCHRON JR. CITRATED APTT TEST GENERATED RESULT OF 113 SECONDS, WHICH WAS HIGHER THAN THE PHYSICIAN'S EXPECTATIONS. SAMPLE TESTED AT THE REFERENCE LABORATORY AND RESULT WAS 47.5 SECONDS. PT MANAGEMENT WAS BASED ON THE LABORATORY RESULT. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72832 HEMOCHRON JR. CITRATE APTT CUVETTE GFO INTERNATIONAL TECHNIDYNE CORP. E3JCC014-P2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR