BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-C3D (MURINE MONOCLONAL) BIOCIONE

    MDR report key: 5453643 · Received February 23, 2016

    Report

    Report Number
    2250051-2016-00004
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 23, 2016
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW, AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. (B)(6) SAMPLE WAS NOT RETURNED TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTING FALSE NEGATIVE RESULT FOR SAMPLE # 05 FOR DIRECT ANTIGLOBULIN TEST ON (B)(6). HOWEVER, INDICATED WHEN FACILITY RECEIVED THEIR SUMMARY REPORT, THE ACTUAL RESULT FOR SAMPLE # 05 SHOULD HAVE BEEN POSITIVE. ACCORDING TO CUSTOMER, SAMPLE WAS FIRST TESTED USING BOTH ORTHO AND IMMUCOR POLYSPECIFC REAGENT AND WAS POSITIVE (2+). WITH ADDITIONAL TESTING USING ORTHO ANTI-C3D BIOCLONE, NO REACTION WAS NOTED. RESULTS WERE REPORTED AS NEGATIVE FOR C3D BIOCLONE. NO QC TESTING PERFORMED ON DAY OF TESTING ACCOUNT DID NOT SPECIFY DAY OF ORIGINAL TESTING.; BUT REPORTED INCIDENT ON (B)(6) 2016 TO OCD FREQUENCY: 1X/ (B)(6) SAMPLE 05. METHODOLOGY USED: TUBE TESTING. SAMPLE TYPE: (B)(6) SAMPLE. CUSTOMER CLAIMED UPON GETTING SUMMARY REPORT, SITE REPEATED TESTING USING ANTI-C3D-LOT # MCD115H (ANOTHER LOT) AND INDICATED SAW MICROSCOPIC WEAK POSITIVE REACTION AFTER RT INCUBATION. CARDS /CASSETTES/RBC STORAGE CONDITION TEMPERATURE: ALL REAGENTS STORED APPROPRIATELY. VISUAL APPEARANCE BEFORE USE: ALL REAGENTS HAVE A NORMAL APPEARANCE PRIOR TO USE. REPEAT TESTING WAS PERFORMED AND CUSTOMER WAS STILL GETTING NEGATIVE WITH LOT # MCD115F AND BARELY POSITIVE WITH MCD115H. OCD DISCUSS POSSIBLE SAMPLE RELATED. CUSTOMER DID INDICATED ACCORDING TO SUMMARY REPORT, FIVE PERCENT OF FACILITIES FAILED THE (B)(6) PROFICIENCY #05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111649 ANTI-HUMAN GLOBULIN ANTI-C3D (MURINE MONOCLONAL) BIOCIONE ANTI-C3D BIOCLONE KSZ ORTHO CLINICAL DIAGNOSTICS MCD115F

    Patients

    Seq Age Sex Outcome Treatment
    1