BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 2491723 · Received March 14, 2012

    Report

    Report Number
    2250051-2012-00040
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 14, 2012
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED VRA165 CELL 4 DID NOT REACT WITH A PATIENT SAMPLE LATER IDENTIFIED TO HAVE ANTI-D. PATIENT HAD A POSITIVE ANTIBODY SCREEN. SAMPLE WAS TESTED WITH PANEL CELLS AND POSITIVE REACTIONS WERE OBSERVED, HOWEVER, CELL 4 DID NOT REACT. CUSTOMER WAS NOT ABLE TO IDENTIFY THE ANTIBODY. SAMPLE WAS SENT TO A REFERENCE LAB; ANTI-D WAS IDENTIFIED. SAMPLE WAS RETESTED AND NO REACTIVITY WAS OBSERVED WITH CELL 4. THE SAMPLE IN QUESTION HAD NO PREVIOUS HISTORY OF ANTIBODIES OR TRANSFUSION HISTORY AT THE CUSTOMER SITE. PATIENT DID NOT REQUIRE ANY TRANSFUSIONS. CUSTOMER STATED THAT QC WAS ACCEPTABLE. CUSTOMER STATED THAT CELL 4 WAS TESTED WITH KNOWN ANTI-D QC MATERIAL AND A 2+ POSITIVE REACTION WAS OBSERVED.

    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 VRA165

    Patients

    Seq Age Sex Outcome Treatment
    1