BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOCHRON JR. ACTIVATED CLOTTING TIME PLUS

    MDR report key: 358228 · Received October 23, 2001

    Report

    Report Number
    2248721-2001-00002
    Event Type
    Other
    Date Received
    October 23, 2001
    Date of Event
    September 24, 2001
    Report Date
    October 23, 2001
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JBP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIALLY ONE USER REPORTED THAT SPECIFIC LOTS OF JACT+ CUVETTES DEMONSTRATED VARIABLE TEST RESULTS WITH SOME RESULTS YIELDING AN "OUT OF RANGE HIGH" RESULT (>1005 SECONDS). THERE WERE NO ADVERSE EVENTS REPORTED BY THE USER. COMPANY'S INVESTIGATION OF THE REPORTED LOTS AS WELL AS OTHER LOTS MANUFACTURED IN THE SAME TIMEFRAME HAS DETERMINED THAT WITH CERTAIN LOTS, THE ACTIVATED CLOTTING TIME (ACT) VARIABILITY IS GREATER THAN EXPECTED PARTICULARLY WHEN THE ANTICIPATED RESULT IS PROLONGED DUE TO THE PRESENCE OF LARGE AMOUNTS OF HEPARIN. COMPANY'S ANALYSIS INDICATES THAT THESE PRODUCT MALFUNCTIONS, WHICH HAVE OCCURRED WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. COMPANY IS SUBMITTING THIS REPORT BASED ON THE COMPANY'S RECEIPT OF SIX (6) FIELD COMPLAINTS, COMPANY'S SUBSEQUENT PRODUCT INVESTIGATION, AS WELL AS, INFORMATION WHICH THE COMPANY LEARNED WAS PLACED ON THE AMSECT (PERFUSIONISTS) SOCIETY "PERFLIST" WEB PAGE BY THE INITIALLY REPORTING PERFUSIONIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47651 HEMOCHRON JR. ACTIVATED CLOTTING TIME PLUS WHOLE BLOOD COAGULATION ASSAY (ACTIVATED CLOTTING TIME) JBP INTERNATIONAL TECHNIDYNE CORP. JACT+ G1JAC115 THROUGH H1JAC135

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other