BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 2631291 · Received June 27, 2012

    Report

    Report Number
    2250051-2012-00128
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 26, 2012
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A PREVIOUSLY IDENTIFIED ANTI-E IS NOW TESTING NEGATIVE WITH VS547. CUSTOMER REPORTS THE TESTING AGAINST LOT# VS547 WAS REPEATED AND CONFIRMED TO BE NEGATIVE. IN (B)(6) 2012, A 1+ REACTION WAS OBSERVED AGAINST VS511 (1+). AN ANTI-E WAS IDENTIFIED USING A 0.8% RESOLVE PANEL, LOT # NOT PROVIDED. THE ANTI-E WAS DETECTED IN THE MTS GEL SYSTEM. ALL DESCRIBED TESTING PERFORMED IN THE MTS ANTI-IGG GEL CARDS LOT# NOT PROVIDED WITH A 15MIN INCUBATION. CUSTOMER DID NOT PERFORM ANY ADDITIONAL TESTING ON THE CURRENT PATIENT SAMPLE SUCH AS AN ANTIBODY IDENTIFICATION PANEL TO COMPARE REACTIVITY WITH THE SCREEN OR AN ANTIBODY TITER. CUSTOMER REPORTS THAT QC TESTING OF LOT# VS547 WAS ACCEPTABLE, HAS NORMAL APPEARANCE AND HAS BEEN STORED ACCORDING TO THE PACKAGE INSERT INDICATIONS. NO REPORTS OF ANY INCORRECT OR ERRONEOUS RESULTS BEING REPORTED AS RESULT OF THIS REPORTED CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS547

    Patients

    Seq Age Sex Outcome Treatment
    1