BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGG ANTIBODIES TO RUBELLA VIRUS

    MDR report key: 5050042 · Received September 2, 2015

    Report

    Report Number
    1823260-2015-04078
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 10, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K072617
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND BOTH REAGENT LOTS PERFORMED WITHIN THE SPECIFIED RANGES OF THE ASSAY. HOWEVER, SOME SAMPLES MAY SHOW DIFFERENCES IN QUANTITATIVE RESULTS. THIS IS PROMINENT FOR SAMPLES CLOSE TO THE CUT OFF. SAMPLES WITH A CONCENTRATION CLOSE TO THE CUT-OFF MAY GIVE DIFFERENT QUALITATIVE RESULTS, MEANING NON-REACTIVE VERSUS REACTIVE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER NOTICED A SHIFT HIGH IN QC RESULTS FOR IGG ANTIBODIES TO RUBELLA VIRUS WHEN CHANGING TO A NEW REAGENT LOT. THE CUSTOMER TESTED PATIENT SAMPLES WITH BOTH LOT NUMBERS OF REAGENT ON COBAS E601 SERIAL NUMBER (B)(4) . OF THE DATA PROVIDED FOR 18 PATIENT SAMPLES, THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 RESULT WITH REAGENT LOT 182963 WAS 8 (NON-REACTIVE). THE RESULT WITH REAGENT LOT 185927 WAS 10 (REACTIVE). PATIENT 2 RESULT WITH REAGENT LOT 182963 WAS 9 (NON-REACTIVE). THE RESULT WITH REAGENT LOT 185927 WAS 12 (REACTIVE). INFORMATION CONCERNING IF ANY DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY OR IF ANY PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580942 IGG ANTIBODIES TO RUBELLA VIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ROCHE DIAGNOSTICS NA 185927

    Patients

    Seq Age Sex Outcome Treatment
    1