BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOCELL-20

    MDR report key: 3746602 · Received April 11, 2014

    Report

    Report Number
    1034569-2014-00055
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 2, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR PRODUCT INVESTIGATION LAB PERFORMED RETENTION PRODUCT TESTING AND CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION PANOCELL-20, LOT 06275 USING TUBE METHODOLOGY WITH RETENTION ANTI-E, LOT 954080. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS FOR PANOCELL 20 LOT 06275. CUSTOMER STATES PATIENT SAMPLE WAS TESTED ON A 2 CELL SCREENING ASSAY ON THE NEO (B)(4). CELL 2 OF THAT SCREEN WAS 3+ POSITIVE. CELL 1 WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220163 PANOCELL-20 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. 06275

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR