BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-K (KEL2)

    MDR report key: 2554378 · Received May 6, 2010

    Report

    Report Number
    9610824-2010-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED LOT 1831190 WAS FILLED FROM BULK LOT V076429. TWO MORE BATCHES, THE LOT 1831198 AND 7831190-01 WERE ALSO FILLED FROM BULK LOT V076429. ALTHOUGH, WE DID NOT RECEIVE ANY COMPLAINT FOR THESE TWO LOTS, THE BATCHES WERE TESTED AND ALSO REACTED FALSE POSITIVE. (B)(6), THE SUPPLIER OF THE BULK MATERIAL FOR SERACLONE ANTI-K (KEL2) WAS INFORMED AND CONFIRMED THE FALSE POSITIVE REACTIONS. THE FALSE POSITIVE REACTIONS WERE ONLY EVIDENT IN A SMALL NUMBER OF KK RED BLOOD CELLS TESTED, AND WERE WEAK, (+) TO 2+, WHEN COMPARED TO THE USUAL 4+ REACTION SEEN WITH K POSITIVE CELLS. ALL OTHER RESULTS TO BE VALID WHERE POSITIVE AND NEGATIVE CONTROLS SHOWED THE EXPECTED REACTIVITY. THE FINAL SEROLOGICAL CONTROL OF ALL LOTS MET ALL ACCEPTANCE CRITERIA. INITIAL INVESTIGATIONS PERFORMED AT (B)(6) HAVE SUGGESTED THAT UPWARD DRIFT IN THE PH OF THE REAGENT DURING THE SHELF-LIFE FROM 5.3 TO 5.6 MAY BE A CONTRIBUTORY FACTOR TO THE OBSERVED WEAK FALSE POSITIVE REACTIONS WITH SOME KK RED BLOOD CELL SAMPLES. AS A CONSEQUENCE OF THE CONFIRMED FALSE POSITIVE REACTIONS ALL AFFECTED LOTS WERE BLOCKED AND A RECALL WAS INITIATED. ONLY THE LOT 7831190-01 WAS DISTRIBUTED TO THE UNITED STATES. (B)(4). (B)(4) ACQUIRED THE (B)(4) ON 1/6/2010. THE COMPANY NAME WAS CHANGED TO (B)(4) ON 3/23/2010.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE POSITIVE REACTIONS WITH SERACLONE ANTI-K (KEL2) ART NO (B)(4) LOT 1831190. THE CUSTOMER INFORMED US ABOUT THEIR TEST RESULTS, BUT DIDN'T SEND BACK THE COMPLAINT SAMPLE AND THE FALSE POSITIVE REACTING RED BLOOD CELLS. THE AFFECTED LOT WAS PRODUCED FROM THE SAME MATERIAL ((B)(4) LOT V076429) AS THE LOT 7831190-09. THE LOT 7831190-09 WAS TESTED IN THE QC LAB AND THE FALSE POSITIVE REACTIONS COULD BE CONFIRMED. (B)(4) WAS INFORMED AND A CORRECTIVE ACTION WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-K (KEL2) SERACLONE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 1831190

    Patients

    Seq Age Sex Outcome Treatment
    1