BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-K SERIES 2 (HUMAN MONOCLONAL)

    MDR report key: 5020871 · Received August 21, 2015

    Report

    Report Number
    1034569-2015-00116
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 20, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN103497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PI LAB CONFIRMED REACTIVITY OF RETENTION ANTI-K LOTS 926018 AND 926019 WITH 4 HETEROZYGOUS K POS CELLS AND 4 K NEG CELLS USING RETENTION PANOCELL-20 LOT 20160 (CELLS 5, 13 AND 17) (POSITIVE REACTIONS WERE 2+) AND RETENTION PANOCELL-10 LOT 24164 (CELLS 6 AND 7). (POSITIVE REACTIONS WERE 1+TO 2+) CONTROLS PERFORMED AS EXPECTED. ALL REAGENT RED CELLS EXHIBITED EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED. PI LAB PERFORMED PHENOTYPE TESTING OF CUSTOMER RETURNED SAMPLE 00724270 CELLS IN TUBE USING RETENTION ANTI-K LOTS 926018 AND 926019. CONTROLS PERFORMED AS EXPECTED. CUSTOMER RETURNED SAMPLE TESTED NEGATIVE WITH BOTH LOTS OF ANTI-K. TESTING WAS REPEATED USING RETENTION ANTI-K LOTS 926018 AND 926019. CONTROLS PERFORMED AS EXPECTED. CUSTOMER RETURNED SAMPLE 00724270 TESTED NEGATIVE WITH BOTH LOTS OF ANTI-K. PERFORMED PHENOTYPE TESTING OF CUSTOMER RETURNED SAMPLE 00724270 CELLS IN TUBE USING RETENTION ANTI-K LOT 924450. CONTROLS PERFORMED AS EXPECTED. CUSTOMER RETURNED SAMPLE TESTED NEGATIVE. TESTING WAS REPEATED USING RETENTION ANTI-K LOT 924450. CONTROLS PERFORMED AS EXPECTED. CUSTOMER RETURNED SAMPLE 00724270 TESTED NEGATIVE. CUSTOMER RETURNED SAMPLE 00724270 DID NOT PERFORM AS EXPECTED. CANNOT RULE OUT A VARIANT FORM OF THE ANTIGEN THAT CANNOT BE DETECTED BY SEROLOGICAL TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH ANTI-K SERIES 2 (HUMAN MONOCLONAL). CUSTOMER REPORTED RESULTS WITH ANTI-K DO NOT MATCH RESULTS OBTAINED WITH THE BIOARRAY HEA BEADCHIP WHICH RESULTED POSITIVE FOR THE KELL ANTIGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554786 ANTI-K SERIES 2 (HUMAN MONOCLONAL) BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 926018

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR