BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE 3ML 9NC COAGULATION SODIUM CITRATE 3.2%

    MDR report key: 2868114 · Received July 6, 2012

    Report

    Report Number
    1125230-2012-00001
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 14, 2012
    Report Date
    July 6, 2012
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 ((B)(4)), AND LESS SO FOR PT ((B)(4)) AND FIBRINOGEN ((B)(4)). 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 SPORADICALLY ON ITEM 454334 LOT B041206 FOR THE PAST TWO WEEKS. THE PT RESULTS WHICH WERE REPORTED TO BE BELOW 20 SEC. WERE SENT TO A SISTER FACILITY AND RUN ON A STAGO AND ALL RESULTS WERE CONFIRMED. THE INSTRUMENT MFR (DADE) WAS BROUGHT IN TO INVESTIGATE THEIR INSTRUMENTATION. THE CUSTOMER THEN HAD 2 COAG TUBES DRAWN ON 10 PATIENTS, ON TUBE FROM LOT NUMBER B041206 AND ONE FROM A NEW LOT NUMBER THAT THE CUSTOMER RECEIVED ON (B)(6) 2012. WHEN RUN ON THEIR INSTRUMENT (SYSMEX 560) EVERY PATIENT REPEATED HIGHER ON THE NEW LOT NUMBER (+1.1 TO +5.7 SECONDS HIGHER).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1