BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2775784 · Received October 8, 2012

    Report

    Report Number
    1034569-2012-00184
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BLUD DIRECT WAS UTILIZED TO REVIEW THE IMAGE RESULTS. ALL TEST WELLS WERE CONSISTENT WITH THE REACTION STRENGTHS REPORTED BY THE INSTRUMENT. THE CUSTOMER INDICATED THAT THEIR SOP DOES NOT ALLOW FOR REPEAT TESTING ON THE INSTRUMENT. THE CUSTOMER ALSO DECLINED SERVICE DUE TO ALL OTHER SAMPLES ON THE SAME PLATE RESULTING AS EXPECTED. QC RESULTED AS EXPECTED. THERE WERE NO ERRORS REPORTED AT THE TIME OF TESTING. THE CUSTOMER SUBMITTED THREE TUBES FROM PATIENT SAMPLE FOR EVALUATION BY (B)(4) PRODUCT INVESTIGATIONS LABORATORY. MANUAL TUBE TESTING WAS PERFORMED USING RETENTIONS ANTI-B SERIES 3, LOT 203382 AND ANTI-B GAMMA CLONE, LOT 205022-2 WITH CUSTOMER'S SUBMITTED SAMPLES, (B)(4) (TUBES A, B, AND C). CUSTOMER'S SAMPLE EXHIBITED NEGATIVE REACTIVITY. A FWD_ABORH ASSAY WAS PERFORMED WITH CUSTOMERS SUBMITTED SAMPLES ON THE GALILEO USING ANTI-B SERIES 3, LOT 203382. QC PERFORMED AS EXPECTED. TUBE A: 1ST RUN RESULTED INV (INVALID) DUE TO INSTRUMENT ERROR. THE REPEAT RUN REPORTED FORWARD AS AN A POS, TUBE B FORWARD AS AN A POS, AND TUBE B WAS CLOTTED AND COULD NOT REPORT VALID RESULTS. ALL SAMPLES PERFORMED AS EXPECTED. THE REACTIVITY OF RETENTION ANTI-B SERIES 3, LOT 203382 DEMONSTRATED EXPECTED REACTIVITY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING AN ABO MISTYPE ON THE GALILEO WITH THE REFLEX ABO A, B ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1