BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 2539998 · Received April 18, 2012

    Report

    Report Number
    1034569-2012-00072
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    March 19, 2012
    Report Date
    April 18, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: BATCH (B)(6), TESTED ON (B)(6) 2012, SAMPLE (B)(6). CMT PLATE: (B)(6), EXP: (B)(6) 2012. MONO CONTROL: LOT#: 492090, EXP: 16JUN2013. ANTI-A: LOT#: 101821, EXP: 09JUN2013. ANTI-B: LOT#: 203402, EXP: 09JUL2013. ANTI-D: LOT#: 504822, EXP: 11AUG2013. MONO CONTROL IS NEGATIVE AND THE WELL VISUALLY APPEARS NEGATIVE WITH A WELL SCORE OF 0. ANTI-A IS NEGATIVE AND THE WELL VISUALLY APPEARS NEGATIVE WITH A WELL SCORE OF 0. ANTI-B IS NEGATIVE AND THE WELL VISUALLY APPEARS NEGATIVE WITH A WELL SCORE OF 0. ANTI-D IS 3+ AND THE WELL VISUALLY APPEARS POSITIVE WITH A WELL SCORE OF 60. BATCH (B)(6), TESTED ON (B)(6) 2012. SAMPLE (B)(6), CMT PLATE: (B)(6), EXP: 03JAN2013. MONO CONTROL: LOT#: 492091, EXP: 16JUN2013. ANTI-A: LOT#: 101832, EXP: 23AUG2013. ANTI-B: LOT#: 203411, EXP: 31AUG2013. ANTI-D: LOT#: 504830, EXP: 28OCT2013. MONO CONTROL FAILED AND THE WELL VISUALLY HAS A BUBBLE IN IT. IT GAVE AN EQUIVOCAL REACTION WITH A WELL SCORE OF 4. ANTI-A IS NEGATIVE AND THE WELL VISUALLY APPEARS NEGATIVE WITH A WELL SCORE OF 0. ANTI-B IS NEGATIVE AND THE WELL VISUALLY APPEARS NEGATIVE WITH A WELL SCORE OF 0. ANTI-D IS POSITIVE AND THE WELL VISUALLY APPEARS POSITIVE. A GRADED REACTION WAS NOT GIVEN, DUE TO THE MONOCONTROL FAILURE. A WELL SCORE OF 82 WAS GIVEN. CUSTOMER TESTED SAMPLE WITH AN ANTI-A1 LECTIN AND IT WAS NEGATIVE. ADVISED THE CUSTOMER THAT THIS MEANS THE PATIENT IS A1 NEGATIVE AND IS A SUBGROUP OF A. THERE IS NO HISTORY ON THE DONOR. ACCORDING TO THE PACKAGE INSERT, VERY WEAK SUBGROUPS (OF A AND B) MAY NOT BE DETECTED BY THESE REAGENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO MISTYPE ON THE ECHO WITH ANTI-A (MURINE MONOCLONAL) SERIES 1. AN A POS SAMPLE RESULTED AS O POS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 101821

    Patients

    Seq Age Sex Outcome Treatment
    1