BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN I AND II

    MDR report key: 5468259 · Received February 29, 2016

    Report

    Report Number
    1034569-2016-00036
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 29, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR PI LAB CONFIRMED REACTIVITY OF THE C ANTIGEN ON CELL 2 (DONOR (B)(4) OF RETENTION CAPTURE R RS (2) PLATES LOT X439 IN MANUAL CAPTURE RETENTION CAPTURE-R INDICATOR CELL (B)(4) WITH RETENTION ANTI-C LOT 6K722 (1:100 DILUTION). CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. PERFORMED 2_CELL SCREEN ON THE NEO WITH RETURN SAMPLE (B)(4) USING RETENTION CAPTURE-R READY SCREEN (2), PLATES LOT X439 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221556. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE GAVE AN EQUIVOCAL REACTION ON CELL 2 (DONOR (B)(4) AND WAS VISUALLY NEGATIVE. RETESTED RETURN SAMPLE WITH SAME LOTS OF REAGENTS AND GAVE EQUIVOCAL REACTION ON CELL 2 (DONOR (B)(4). CELL 2 WAS VISUALLY NEGATIVE. PERFORMED ANTIBODY ID ON NEO WITH RETURN SAMPLE (B)(4) USING RETENTION CAPTURE-R READY ID PLATES LOT ID289, RETENTION CAPTURE-R INDICATOR CELLS LOT 221556. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE RESULTED POSITIVE WITH C POSITIVE CELLS AND NEGATIVE WITH C NEGATIVE CELLS. POSITIVE REACTIONS WERE 2-4+. REPRODUCED CUSTOMER OBSERVATION. A DHR REVIEW WAS PERFORMED ON CAPTURE R READY SCREEN I, II LOT X439 FOR C ANTIGEN STATUS OF CELL II (DONOR (B)(4) PRIOR TO RELEASE. DHR QUALITY REVIEW DEEMED ALL SPECIFICATIONS AS BEING MET AND RELEASED PRODUCT TO MARKET ON (B)(6) 2016. THE UNEXPECTED REACTIVITY APPEARS TO BE UNIQUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN I AND II ON A GALILEO NEO INSTRUMENT. PATIENT HAS AN ANTI-C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123765 CAPTURE-R READY-SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X439

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR