BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2476122 · Received March 2, 2012

    Report

    Report Number
    1034569-2012-00038
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 3, 2012
    Report Date
    March 2, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: BATCH 17405, 17409 TESTED ON 03FEB2012 DATA ARCHIVED; SCREEN LOTS USED: CRRS3 LOTS R193 AND R205; CRRIC LOT 221771; LOT R193: SCI 2+ SCII NEG SCIII NEG SCI FY(A-B+) SCII FY(A+B+) SCIII FY(A+B-); LOT R205: SCI NEG SCII NEG SCIII NEG SCI FY(A-B+) SCII FY(A+B+) SCIII FY(A+B-). BATCH 17409 SAMPLE H07840 ON S/N (B)(4) RAN ON 03FEB2012: CCRS3 LOT R205 AND CRRIC LOT 221771; SCI, SCII AND SCIII NEGATIVE POS CTRL 4+ SCI B7854 FY(A-B+) SCII C4940 FY(A+B+) SCIII FY(A+B-). DISCUSSED WITH CUSTOMER THAT SOME OF THE CELLS WITH POSITIVE FY(B) DONORS DID NOT REACT WITH THE SAMPLE PLASMA COULD BE ATTRIBUTED TO THE WEAK EXPRESSION OF THE FY(B) ANTIBODY FOR THIS PARTICULAR PATIENT. NO SAMPLE AVAILABLE TO SEND TO IMMUCOR FOR FURTHER INVESTIGATION. CUSTOMER WAS SATISFIED WITH THE INVESTIGATION AND DID NOT REQUIRE FURTHER ASSISTANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-R READY SCREEN 3 (CRRS3) WHEN TESTING A PATIENT SAMPLE ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R193

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR