BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT-LR CUVETTE ASSAY (HEMOCHRON ELITE SYSTEM)

    MDR report key: 2475666 · Received February 15, 2012

    Report

    Report Number
    2248721-2012-00012
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 24, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JBP
    PMA / PMN Number
    K960749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER TESTED USING INSTRUMENT SERIAL NUMBERS (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED (SINGLE-USE DISPOSABLE). PROCESS EVALUATION PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS INCONSISTENT ACT-LR RESULTS WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM WHILE MONITORING FEMALE INFANT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). SITE RETESTED BY RUNNING COMPARATIVE TEST ON 2 INSTRUMENTS SIMULTANEOUSLY. NINE SETS OF SAMPLES WERE TESTED AND TWO GENERATED ACT-LR RESULTS WITH SIGNIFICANT VARIATION. PATIENT'S HEPARIN DRIP WAS NOT ADJUSTED BASED OF THESE RESULTS. SYSTEM PASSED ELECTRICAL QUALITY CONTROL AND LIQUID QUALITY CONTROL. FOLLOW-UP WITH CUSTOMER TWO WEEKS LATER INDICATED ACT-LR RESULTS STABILIZED AND CUSTOMER DID NOT WISH TO RETURN INSTRUMENT OR CUVETTES FOR FURTHER INVESTIGATION. PATIENT ON HEPARIN DRIP OF 1.9 CC/HR AND THE HEPARIN CONCENTRATION IS 60 UNITS/CC. TARGET TIME: 210-240 SECONDS. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT-LR CUVETTE ASSAY (HEMOCHRON ELITE SYSTEM) JBP INTERNATIONAL TECHNIDYNE CORP. M1JLR189

    Patients

    Seq Age Sex Outcome Treatment
    1