BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLVE PANEL B

    MDR report key: 2033570 · Received March 30, 2011

    Report

    Report Number
    2250051-2011-00060
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING AND A BATCH RECORD REVIEW WAS PERFORMED. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT RB309 CELL 18 DID NOT REACT WITH A SAMPLE CONTAINING ANTI-D. DAILY QC WAS ACCEPTABLE. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLVE PANEL B REGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS RB309

    Patients

    Seq Age Sex Outcome Treatment
    1