BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON ELITE MICROCOAGULATION SYSTEM

    MDR report key: 2103309 · Received May 18, 2011

    Report

    Report Number
    2248721-2011-00068
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 29, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K050016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (CUVETTE LOT #L0JLR170). METHOD: DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. DEVICE HISTORY RECORD FOR CUVETTE LOT WAS REVIEWED AND MET SPECIFICATIONS. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION COULD BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM "GOT LOWER RESULT ON ACT-LR THAN EXPECTED". ERRATIC RESULTS WERE GENERATED. THE TEST WAS REPEATED IMMEDIATELY WITH EXPECTED RESULTS. LIQUID QUALITY CONTROLS PERFORMED POST-EVENT FAILED. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON ELITE MICROCOAGULATION SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1