BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANOCELL

    MDR report key: 806458 · Received January 5, 2007

    Report

    Report Number
    1034569-2007-00008
    Event Type
    Malfunction
    Date Received
    January 5, 2007
    Date of Event
    December 7, 2006
    Report Date
    January 5, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CELL #7 AND CELL #16, JS (A+B+) FROM RETENTIONS OF PANOCELL-20, LOT 43541 AND PANOCELL-16, LOT 43524 RESPECTIVELY, WERE TESTED WITH THE PATIENT'S SAMPLE USING PEG, LOT PEG61-2 AS THE POTENTIATOR. THE PATIENT'S SAMPLE EXHIBITED NO REACTIVITY WITH CELL #7 FROM RETENTION PANOCELL-20, LOT 43541 AND 2+ REACTIVITY WITH CELL #16 FROM RETENTION PANOCELL-16, LOT 43524.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS WITH CELL #7 (DONOR #C3471), JS (A+), OF PANOCELL 20, LOT 43541, WHEN TESTING 2 PATIENTS WITH PREVIOUS HISTORY OF ANTI-JSA. REPEAT TESTING PERFORMED WITH OTHER JS (A+) CELLS, CELL #16 (DONOR #N583) OF PANOCELL 16, LOT# 43524 AND CELL # 4 (DONOR #D633) OF PANOCELL 10, LOT 42518 RESULTED IN 2+ OR GREATER REACTIVITY. TESTING WAS PERFORMED USING THE TUBE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANOCELL REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. * 43541

    Patients

    Seq Age Sex Outcome Treatment
    1 *