BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 1860123 · Received October 7, 2010

    Report

    Report Number
    2250051-2010-00220
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. RESULTS WERE SATISFACTORY. CUSTOMER SUSPECTS THE ISSUE LIES WITH THE SAMPLE IN QUESTION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VRA147 CELL 3 DID NOT REACT WITH A PATIENT SAMPLE WITH A PREVIOUS HISTORY OF ANTI-E. CUSTOMER REPORTED CELL 6 (E+E+) WAS 1+. DAILY QC WAS ACCEPTABLE. CUSTOMER HAD TESTED THE PANEL A LOT IN QUESTION WITH OTHER SAMPLE YESTERDAY IN WHICH AN ANTI-E WAS CLEARLY IDENTIFIED WITHOUT ISSUE. CUSTOMER SUSPECTS THE ISSUE LIES WITH THE SAMPLE IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVE PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VRA147

    Patients

    Seq Age Sex Outcome Treatment
    1