BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVE PANEL A

    MDR report key: 2050788 · Received April 12, 2011

    Report

    Report Number
    2250051-2011-00071
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 10, 2011
    Report Date
    November 13, 2012
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. RESULTS WERE SATISFACTORY. BASED ON THE LACK OF INFORMATION REGARDING THE ALLEGED TRANSFUSION REACTION, OCD'S MEDICAL DIRECTOR HAS DETERMINED THAT A SERIOUS INJURY HAD OCCURRED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ANTIBODY SCREEN RESULTED 1+ POSITIVE ON A PATIENT SAMPLE WITH NO PREVIOUS HISTORY. TESTING WAS THEN PERFORMED WITH VRA153 AND NO REACTIVITY WAS OBSERVED. CUSTOMER THEN PERFORMED A TUBE LISS CROSSMATCH WITH TWO UNITS. COMPATIBLE RESULTS WERE OBSERVED. THE TWO UNITS WERE TRANSFUSED. CUSTOMER REPORTED THAT A TRANSFUSION REACTION HAD OCCURRED. ONE UNIT WAS POSITIVE FOR THE E ANTIGEN. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER.

    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 VRA153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other