BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED)

    MDR report key: 1576560 · Received January 13, 2010

    Report

    Report Number
    1034569-2010-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 13, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE TESTED THE SAMPLE (B)(6) MANUALLY IN TUBE TEST WITH PANOCELL-16 LOT: 46820 EXP. DATE: 2010-01-22 CELL 1 (FYA POSITIVE HETEROZYGOUS), CELL 3 (FYA POSITIVE HOMOZYGOUS). THE RESULTS WERE NEGATIVE AT 4 DEGREE C, RT, 37 DEGREE C AND ICT. KNOWN POSITIVE SAMPLE REACTED AS EXPECTED. WE TESTED THE SAMPLE (B)(6) ON OUR IN HOUSE GALILEO SN (B)(4) WITH CAPTURE-R (POOLED) LOT: CW203 EXP. DATE: 2010-01-19 USING LISS LOT: 211800 EXP. DATE: 2010-08-14 AND CRIC LOT: 221439 EXP. DATE: 2009-12-24. THE RESULT WAS POSITIVE. A KNOWN ANTI-FY(A) POSITIVE SAMPLE REACTED AS EXPECTED. WE TESTED THE SAMPLE (B)(6) IN THE GEL CARD SYSTEM, CELL 1 (FYA POS HOMOZYGOUS) AND THE RESULT WAS (+), CELL 2 (FYA POS HETEROZYGOUS) AND THE RESULT WAS NEGATIVE. ADDITIONALLY, WE TESTED THE SAME SAMPLE WITH 2 FYA POS AND HOMOZYGOUS CELLS WITH PROLONGED INCUBATION TIME AND THE RESULTS WERE 1+ TO 2+. THE EVENT APPEARS TO BE DUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A SAMPLE WITH A KNOWN ANTI-FYA WITH CAPTURE-R READY SCREEN (CRRS) (POOLED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (POOLED) REAGENT RED BLOOD CELLS KSZ IMMUCOR CW203

    Patients

    Seq Age Sex Outcome Treatment
    1