BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 1572066 · Received January 8, 2010

    Report

    Report Number
    1034569-2010-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 7, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: TESTING PERFORMED ON (B)(6) 2009. INTERPRETATION: NEGATIVE. EXPECTED INTERPRETATION: NO PRIOR TESTING. IMAGE DESCRIPTION: LOOKS AS THOUGH THERE IS A WEAK RXN. REACTION STRENGTH: 18. NOTE: CAPTURE-R INDICATOR CELL LOT 221434 EXP 12-03-09 USED DURING THIS TESTING. NEW SAMPLE FROM SAME PATIENT. TESTING PERFORMED ON (B)(6) 2009. INTERPRETATION: POSITIVE. EXPECTED INTERPRETATION: NEGATIVE (BASED ON PREVIOUS TESTING). IMAGE DESCRIPTION: LOOKS POSITIVE. REACTION STRENGTH: 82. NOTE: CAPTURE-R INDICATOR CELL LOT 221441 EXP 12-17-09 USED DURING THESE TEST. REPEAT TESTING; INTERPRETATION: POS. EXPECTED INTERPRETATION: POS (BASED ON PREVIOUS TESTING). IMAGE DESCRIPTION: LOOKS POS. REACTION STRENGTHS: NOT PROVIDED BY THE CUSTOMER (REACTION GRADE 1+). SECOND SAMPLE FROM SAME PATIENT: INTERPRETATION: POS. EXPECTED INTERPRETATION: POS (BASED ON PREVIOUS TESTING). IMAGE DESCRIPTION: LOOKS POS. REACTION STRENGTH: NOT PROVIDED BY THE CUSTOMER (REACTION GRADE 1+). NOTE: IND CELL LOT 22441 EXP 12-17-09 USED DURING TESTING. THE REPEAT TESTING WITH A DIFFERENT LOT OF CAPTURE-R READY INDICATOR CELLS RESULTED AS POSITIVE ON THE SAME INSTRUMENT THAT REPORTED THE INITIAL UNEXPECTED NEGATIVE RESULT. THE INITIAL TESTING PERFORMED ON (B)(6) 2009 SHOWED A SLIGHT REACTION. CANNOT RULE OUT THAT THE VIAL OF CAPTURE-R READY INDICATOR CELLS MAY HAVE BEEN COMPROMISED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WHEN TESTING A PATIENT SAMPLE BY POOLED_SCREEN ASSAY ON THE GALILEO USING CAPTURE-R READY INDICATOR CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS KSZ IMMUCOR 221434

    Patients

    Seq Age Sex Outcome Treatment
    1