BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN I AND II

    MDR report key: 2223605 · Received August 25, 2011

    Report

    Report Number
    1034569-2011-00123
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 25, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CAPTURE-R READY-SCREEN (2) (CRRS2) LOT X340, EXPIRED PRIOR TO COMPLAINT BEING REFERRED TO PRODUCT INVESTIGATION LAB. A DHR REVIEW WAS PERFORMED TO SHOW REACTIVITY OF D ANTIGEN AT THE TIME OF PRODUCT RELEASE. BULK TESTING: BOTH CELLS = 4+ (CONTROL = 4+ ANTI-D LOT 6K562); WET PLATE: BOTH CELLS = 9 (ANTI-D LOT DL13575F); MANUFACTURING DRY PLATE: BOTH CELLS =8 (ANTI-D LOT DL13575F); FINAL RELEASE: BOTH CELLS = 8 (ANTI-D LOT 0D547-C); ALL OTHER TESTING DOCUMENTED REQUIREMENTS WERE MET / PASS. NO UNPLANNED DEVIATIONS OR OOS RECORDS RAISED. PRODUCT WAS APPROVED FOR RELEASE INTO FINISHED GOODS ON (B)(4) 2011.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY SCREEN (CRRS) I AND II ON THE GALILEO. REPEAT TESTING PERFORMED ON A NEW LOT OF CRRS I AND II RESULTED (B)(6). THE SAMPLE WAS TESTED WITH CAPTURE-R READY ID AND AN ANTI-D WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X340

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR