BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-D BIOCLONE

    MDR report key: 1445031 · Received August 10, 2009

    Report

    Report Number
    2250051-2009-00222
    Event Type
    Malfunction
    Date Received
    August 10, 2009
    Date of Event
    July 15, 2009
    Report Date
    August 10, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAINED TESTING OF THIS LOT OF PRODUCT. ALL RESULTS WERE AS EXPECTED. CUSTOMER SENT PATIENT #2 SAMPLE TO A REFERENCE LAB THAT USES COMPETITOR REAGENTS. PATIENT SAMPLE REACTED AT IMMEDIATE SPIN. PATIENT #1 SAMPLE WAS QNS FOR ANY FURTHER INVESTIGATION. CUSTOMER STATED THAT QC WAS SATISFACTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO PATIENTS, PREVIOUSLY TYPED AS WEAK D POSITIVE, ARE NEGATIVE AT ALL PHASES OF TESTING. PATIENT #1 TESTED WEAK D POSITIVE IN 2006 USING ORTHO ANTI-D (LOT NOT PROVIDED). PATIENT #2 TESTED WEAK D POSITIVE IN 2009 USING DB272A1. REPEAT TESTING WAS PERFORMED ON SAMPLES BY OTHER TECHS. NO REACTIVITY WAS OBSERVED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-D BIOCLONE BLOOD GROUPING REAGENTS KSZ ORTHO-CLINICAL DIAGNOSTICS DB272A1

    Patients

    Seq Age Sex Outcome Treatment
    1