BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 2439674 · Received February 6, 2012

    Report

    Report Number
    1034569-2012-00016
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    December 22, 2012
    Report Date
    February 2, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES: (B)(4), ID152 21DEC2011 11:44. THE FOLLOWING CELLS ARE JKA POSITIVE: 1,4,5,7,8,9,10,11,12,13 & 14. SAMPLE ID (B)(4). THE ECHO GENERATED NEGATIVE RESULTS FOR ALL CELLS. CELL 1: NEGATIVE VISUALLY APPEARED NEGATIVE. CELL 4: NEGATIVE VISUALLY APPEARED NEGATIVE. CELL 5 NEGATIVE VISUALLY APPEARED NEGATIVE. CELL 7: NEGATIVE VISUALLY APPEARED NEGATIVE. CELL 8: NEGATIVE VISUALLY APPEARED NEGATIVE. CELLS 9-14: NEGATIVE VISUALLY APPEARED POSITIVE. CELLS 9-14 ARE HOMOZYGOUS. UNABLE TO RULE OUT ANTIBODY SHOWING DOSAGE. POS CTRL: 4+ NEG CTRL: (B)(4), EXTEND I DP052 21DEC2011 14:27. THE FOLLOWING CELLS ARE JKA POSITIVE: 1,3,4,5,7,8,9,12 & 14. SAMPLE ID (B)(4). CELL 1: NEGATIVE VISUALLY APPEARS NEGATIVE. CELL 3: NEGATIVE VISUALLY APPEARS NEGATIVE. CELL 4: NEGATIVE VISUALLY APPEARS NEGATIVE. CELL 5: 2+ VISUALLY APPEARS POSITIVE. *CELL 7: NEGATIVE VISUALLY APPEARS POSITIVE. *CELL 8: NEGATIVE VISUALLY APPEARS POSITIVE. *CELL 9: NEGATIVE VISUALLY APPEARS POSITIVE. CELL 12: 1+ VISUALLY APPEARS POSITIVE. *CELL 14: NEGATIVE VISUALLY APPEARS POSITIVE. POS CTRL: 4+ NEG CTRL: 0. (B)(4), 21DEC2011 11:27 CELL 3 IS JKA POSITIVE. CELL 3: NEGATIVE VISUALLY APPEARS POSITIVE. POS CTRL: 4+. NEGATIVE WELL INTERPRETATIONS THAT VISUALLY APPEAR POSITIVE ARE ADDRESSED INTECHNICAL COMMUNICATION (B)(4) ISSUED ON (B)(4) 2009.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON CAPTURE-R READY SCREEN (CRRS) AND CAPTURE-R READY ID (CRRID) WHEN TESTING A PATIENT SAMPLE KNOWN TO HAVE AN ANTI-JKA ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID152

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR