BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 2241924 · Received September 9, 2011

    Report

    Report Number
    1034569-2011-00136
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 9, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETRIEVED BATCH FILES. SAMPLE (B)(6) BATCHES 2283, 2310, AND 2305. SAMPLE ID: (B)(6); INSTRUMENT S/N: (B)(4); DATE TESTED: (B)(6) 2011; BATCH: 2283; LOT NUMBERS: CRRS 3 R163, 221699. CELL 1 REACTED NEGATIVE; NEGATIVE FOR E, VISUAL APPEARANCE NEGATIVE. CELL2 REACTED NEGATIVE HOMOZYGOUS FOR E, VISUAL APPEARANCE WEAK POSITIVE (THIS IS BEING INVESTIGATED UNDER (B)(4)). CELL 3 REACTED NEGATIVE; NEGATIVE FOR E, VISUAL APPEARANCE NEGATIVE. POSITIVE CONTROL WELL REACTED 4+ POSITIVE, VISUAL APPEARANCE POSITIVE. SAMPLE ID: (B)(6) INSTRUMENT S/N: (B)(4); DATE TESTED: (B)(6) 2011; BATCH: 2305; LOT NUMBERS: CRRS 3 R167, 221699. CELL 1 REACTED NEGATIVE; NEGATIVE FOR E, VISUAL APPEARANCE NEGATIVE. CELL2 REACTED 2+ POSITIVE, HOMOZYGOUS FOR E, VISUAL APPEARANCE POSITIVE. CELL 3 REACTED NEGATIVE, NEGATIVE FOR E, VISUAL APPEARANCE NEGATIVE. POSITIVE CONTROL WELL REACTED 4+ POSITIVE, VISUAL APPEARANCE POSITIVE. SAMPLE ID: (B)(6); INSTRUMENT S/N: (B)(4); DATE TESTED: (B)(6) 2011; BATCH: 2310; LOT NUMBERS: ID144, 221699. CELL 1 REACTED NEGATIVE; HETEROZYGOUS FOR E; VISUAL APPEARANCE NEGATIVE. CELL2 REACTED EQUIVOCAL; NEGATIVE FOR E ; VISUAL APPEARANCE WEAK POSITIVE. CELL 3 REACTED 2+ POSITIVE; HOMOZYGOUS FOR E; VISUAL APPEARANCE POSITIVE. CELL 4 REACTED EQUIVOCAL; NEGATIVE FOR E; VISUAL APPEARANCE WEAK POSITIVE. CELL 5 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE NEGATIVE. CELL 6 REACTED NEGATIVE; HETEROZYGOUS FOR E; VISUAL APPEARANCE NEGATIVE. CELL 7 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE NEGATIVE. CELL 8 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE NEGATIVE. CELL 9 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE NEGATIVE. CELL 10 REACTED 3+ POSITIVE; NEGATIVE FOR E; VISUAL APPEARANCE POSITIVE. CELL 11 REACTED EQUIVOCAL; NEGATIVE FOR E; VISUAL APPEARANCE WEAK POSITIVE. CELL 12 REACTED EQUIVOCAL; NEGATIVE FOR E; VISUAL APPEARANCE WEAK POSITIVE. CELL 13 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE WEAK POSITIVE. CELL 14 REACTED NEGATIVE; NEGATIVE FOR E; VISUAL APPEARANCE NEGATIVE. POSITIVE CONTROL WELL REACTED 4+ POSITIVE; VISUAL APPEARANCE POSITIVE. NEGATIVE CONTROL WELL REACTED NEGATIVE; VISUAL APPEARANCE NEGATIVE. UPON FOLLOW-UP WITH CUSTOMER, SHE REPORTED THE CRRS 3 STRIPS IN THE POUCH WERE SOME HOW COMPROMISED. SHE STATED THAT SHE REMINDED HER STAFF TO CONTINUE TO VERIFY THE HUMIDITY CARD AND TO RESEAL ALL POUCHES SECURELY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE TESTED WITH CAPTURE-R READY SCREEN (CRRS) 3 LOT R163 ON THE ECHO. THE PATIENT HAS A HISTORY OF AN ANTI-K. TESTING WAS REPEATED ON THE ECHO USING CRRS 3 LOT R167 AND RESULTED POSITIVE. ADDITIONAL INFORMATION FROM FDA MEDFORM 3500A FROM BOSTON MEDICAL, NOT REPORTED TO IMMUCOR BY THE CUSTOMER: PATIENT PRESENTED TO ER WITH SIGNS AND SYMPTOMS OF A DELAYED HEMOLYTIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R163

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR