BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION TUBES WITH SODIUM CITRATE

    MDR report key: 2633035 · Received June 21, 2012

    Report

    Report Number
    2633035
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 21, 2012
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    GIM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGISTS IN THE COAGULATION LABORATORY OBSERVED THAT WE WERE RECEIVING AN ABNORMAL NUMBER OF SPECIMENS WITH VERY SHORT CLOTTING TIMES LESS THAN 20 SECONDS FOR A PTT (PROTHROMBIN TIME)TEST WHICH WERE BEING HELD IN THE ANALYZER INTERFACE. THESE SPECIMENS ARE CHECKED FOR A CLOT. RECOLLECTION IS RECOMMENDED AS A TRAUMATIC COLLECTION IS SUSPECTED.THE VENDOR WAS CONTACTED TO RULE OUT A ANALYZER ISSUE. THE VENDOR CHECKED OUT THE ANALYZER AND NO PROBLEMS WERE DETECTED. THE HEMATOLOGY LAB HAS 2 OF THE ANALYZERS IN QUESTION AND SHORT SECONDS WERE OBSERVED ON BOTH ANALYZERS. THE HEMATOLOGY SUPERVISOR THEN CONTACTED THE NURSE EDUCATOR FOR THE ED (EMERGENCY DEPARTMENT) WHERE THE SPECIMENS WERE BEING COLLECTED. THE NURSE MANAGER INVESTIGATED IF THE SPECIMENS WERE BEING COLLECTED BY NEW STAFF OR ANY OTHER COLLECTION CHANGES. THE NURSE MANAGER FOUND THAT THE SPECIMENS WERE BEING COLLECTED BY EXPERIENCED STAFF. THE HEMATOLOGY SUPERVISOR OBSERVED THAT THE SHORTENED TIMES ON THE PTTS WAS ON A SPECIFIC LOT NUMBER OF 3.2% SODIUM CITRATE TUBES MANUFACTURED BY GRENIER. THE LOT WAS PULLED. THE SHORTENED PTT RESULTS FROM THE ED PATIENTS ARE BEING MONITORED DAILY AND ARE NO FURTHER INACCURACIES HAS BEEN IDENTIFIED, SINCE THE TUBES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUETTE BLOOD COLLECTION TUBES WITH SODIUM CITRATE SODIUM CITRATE BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NORTH AMERICA, INC. * B041206

    Patients

    Seq Age Sex Outcome Treatment
    1 *