BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-E (MONOCLONAL) SERIES 1

    MDR report key: 1665643 · Received April 23, 2010

    Report

    Report Number
    1034569-2010-00097
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 22, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 103477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED FOUR E+E+ AND FOUR E-E+ REAGENT RED CELLS FROM RETENTION PANOSCELL-16 AND CELL 6 E+E+ FROM RETENTION PANOCELL-10 WITH RETENTION ANTI-E, LOT 955002. THE EXPECTED REACTIVITY WAS OBSERVED. TESTED FOUR E+E+ AND FOUR E-E+ REAGENT RED CELLS FROM RETENTION PANOSCELL-16 AND CELL 6 E+E+ FROM RETENTION PANOCELL-10 WITH RETURNED ANTI-E, LOT 955002. THE EXPECTED REACTIVITY WAS OBSERVED. RETURNED AND RETENTION ANTI-E SERIES 1, LOT 955002, WAS TESTED WITH ONE SEGMENT OF WHOLE BLOOD. THE SEGMENT WAS ALSO TESTED WITH GAMMA-CLONE ANTI-E (MONOCLONAL). POSITIVE REACTIVITY (3+) WAS OBSERVED WITH ALL ANTI-E REAGENTS TESTED. RETURNED PRODUCTS PERFORMED AS EXPECTED. WE WERE UNABLE TO REPRODUCE THE CUSTOMER'S OBSERVATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TESTING A DONOR SAMPLE WITH ANTI-E (MONOCLONAL) SERIES 1. CUSTOMER BECAME AWARE OF THE ERROR WHILE PERFORMING A CROSSMATCH ASSAY. CUSTOMER TESTED THE DONOR SAMPLE WITH ANOTHER VIAL OF SAME LOT AND RECEIVED 1+ REACTIVITY AFTER 5 MINUTES OF INCUBATION AT 37C. CUSTOMER IS STILL GETTING NEGATIVE RESULTS WITH THE FIRST VIAL OF REAGENT. CUSTOMER STATED THAT PATIENT DID NOT RECEIVE IMPROPER UNITS FOR TRANSFUSION DUE TO THE UNEXPECTED NEGATIVE REACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-E (MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR 955002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR