BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5162608 · Received October 20, 2015

    Report

    Report Number
    1034569-2015-00159
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 20, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED BATCH IMAGES: ON BATCH 31997 SAMPLE M22174 USING LOTS R649/221460/LISS 211600 CELL 1 NEG VISUALLY NEG CELL 2 4+ VISUALLY POS CELL 3 3+ VISUALLY POS CTRL WELL REACTED AS EXPECTED CELL 1 DONOR B7282 C- E- K+ JKA+ CELL 2 C+E+K-JKA- CELL 3 C+E-K-JKA+ MISSED KELL AND JKA ANTIBODY ON CELL 1. PI LAB CONFIRMED THE REACTIVITY OF THE JKA AND K ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (3), LOT R649 AND THE K ANTIGEN ON RETENTION CAPTURE-R READY-ID EXTEND I, LOT DP081, IN MANUAL CAPTURE, USING ANTI-JKA AND ANTI-K ANTISERA. CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT CELLS EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. CAPTURE-R SELECT LOT SC303, EXPIRED PRIOR TO START OF INVESTIGATION. A DHR REVIEW WAS PERFORMED ON CAPTURE-R SELECT LOT SC303 FOR PERFORMANCE WITH THE CROSSMATCH ASSAY ON THE ECHO PRIOR TO RELEASE. DHR REVIEW: QUALITY CONTROL - FINAL RELEASE: ECHO INSTRUMENTATION: PERFORMED ON 26SEP2014 CROSSMATCH ASSAY PERFORMED, 6 REPLICATES OF KNOWN ANTIBODY NEGATIVE (INERT) IN-HOUSE DONORS RESULTED NEGATIVE AS EXPECTED. ALL CONTROL WELLS RESULTED POSITIVE AS EXPECTED ALL WELLS WERE VISUALLY VERIFIED. DHR QUALITY REVIEW DEEMED ALL SPECIFICATIONS AS BEING MET AND RELEASED PRODUCT TO MARKET ON 27OCT2014.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MISSED ANTI-JKA AND ANTI-KELL WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN 3 (CRRS3) ON A GALILEO ECHO INSTRUMENT. THE CUSTOMER ALSO REPORTED AN UNEXPECTED NEGATIVE RESULT ON THE SAME SAMPLE WHEN CROSSMATCHED WITH JKA POSITIVE RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691080 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R649

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR