BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE 3ML 9NC COAGULATION SODIUMCITRATE 3.2%

    MDR report key: 2656294 · Received July 9, 2012

    Report

    Report Number
    1125230-2012-00002
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Date of Event
    June 7, 2012
    Report Date
    July 9, 2012
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ERROR RATE: (B)(4) OF THE MANUFACTURED LOT MAY BE CONCERNED. CITRATE IS AN ANTICOAGULANT, WHICH BINDS CALCIUM AND THUS INHIBITS THE COAGULATION. ANALYTICAL RESULTS FOR COAGULATION DEPEND ON THE RATIO OF CITRATE TO BLOOD. THIS CONCENTRATION OF CITRATE WAS INCORRECT IN PART OF THE LOT ((B)(4) OF TUBES). INTERNAL TESTING DETERMINED THAT DEVIATION WAS MOST APPARENT FOR PTT VALUES (-11 TO -19%), AND LESS SO FOR PT (-2 TO -5%) AND FIBRINOGEN (+1.6 TO -6.5%). THE LOWER CONCENTRATION OF CITRATE SOLUTION MAY HAVE THE FOLLOWING EFFECTS: SHIFT HIGHER, PATHOLOGICAL VALUES INTO THE NORMAL REFERENCE RANGE SO THAT VALUES APPEAR HEALTHY OR LOW FOR THE DESIRED PROPHYLAXIS OR ANTICOAGULANT THERAPY (MAIN RISK). SHIFT NORMAL VALUES OUT OF THE LOWER REFERENCE AND/OR ANALYTICAL RANGE, SO THAT VALUES APPEAR ABNORMALLY LOW AND ARE FLAGGED BY INSTRUMENTATION (MINOR RISK). THE GREATEST DEVIATION WAS OBSERVED WITH PTT. THUS, THE MAIN CONCERN IS THAT HIGHER PATHOLOGICAL VALUES MAY APPEAR NORMAL OR ANTICOAGULANT THERAPY BE ADJUSTED AS A RESULT OF FALSELY LOW VALUES.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY HAVE BEEN EXPERIENCING DECREASED PTT RESULTS ON ITEM 454334, LOT B041206 SINCE (B)(6). THE PATIENT RESULTS WERE REPORTED TO BE 21 TO BELOW 20 SEC. THE SAMPLES WERE DRAWN USING GREINER PRODUCTS. THEY ARE SENDING DATA IN BY FAX FOR SUBMISSION TO QA. THEY HAVE NOT BEEN ABLE TO MAKE A DETERMINATION CONCERNING ANY VARIATION IN PT RESULTING AT THIS TIME. THEY ARE USING SYSMEX INSTRUMENTATION AND THE CONTROLS ARE WITHIN SPEC AND INSTRUMENTATION MAINTENANCE ACCEPTABLE ACCORDING TO THEIR INSTRUMENT MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUETTE 3ML 9NC COAGULATION SODIUMCITRATE 3.2% COAGULATION BLOOD COLLECT.TUBE GIM GREINER BIO-ONE NORTH AMERICA, INC. 454334 B041206

    Patients

    Seq Age Sex Outcome Treatment
    1