BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGG ANTIBODIES TO RUBELLA VIRUS

    MDR report key: 3308183 · Received August 26, 2013

    Report

    Report Number
    1823260-2013-05146
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Date of Event
    July 23, 2013
    Report Date
    September 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K072617
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE TESTED WITH TWO LOTS OF THE RUBG REAGENT, LOT NUMBERS 171228 AND 172933, ON AN ANALYTIC E MODULE. THE CUSTOMER'S NEGATIVE RESULTS COULD BE REPRODUCED FOR BOTH LOTS OF REAGENT. AN INTERFERENCE ANALYSIS WAS PERFORMED AND BOTH SAMPLES GAVE POSITIVE/REACTIVE RESULTS. RECOMBINANT BLOT ANALYSIS WAS PERFORMED AND BOTH SAMPLES SHOWED IDENTICAL BANDS THAT WERE INTERPRETED AS POSITIVE. THE QUALITY CONTROL RESULTS FROM THE TIME OF THE EVENT WERE WITHIN RANGE. THE ELECSYS RUBG RESULT WAS MOST LIKELY A FALSE NEGATIVE RESULT. THIS ISSUE IS UNUSUAL AS THE ROCHE ASSAY USES RECOMBINANT E1 AND RECOMBINANT RUBELLA VIRUS STRUTURES FOR DETECTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE IGG ANTIBODIES TO RUBELLA VIRUS (RUBG) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S INITIAL RUB RESULT WAS 7.84 UI/ML WHICH WAS A NON-REACTIVE RESULTS AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT HAD BEEN FOUND POSITIVE IN OTHER LABORATORIES AND WAS SURPRISED TO HAVE A NEGATIVE RESULT. ON (B)(6) 2013, THE PATIENT'S SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A LIAISON DIASORIN ANALYZER. THE RESULT WAS 23 UI/ML WHICH WAS POSITIVE AND IT WAS CORRECTED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT'S SAMPLE WAS REPEATED ON THE INITIAL ANALYZER AND THE RESULT WAS 6.66 UI/ML WHICH WAS A NON-REACTIVE RESULT. THE CUSTOMER PROVIDED AN ADDITIONAL RUBG RESULT OF 7.65 UI/ML FOR THIS PATIENT FROM (B)(6) 2013. IT WAS UNCLEAR IF THIS RESULT WAS FROM THE SAME SAMPLE AS THE INITIAL DISCREPANT RESULT. CLARIFICATION HAS BEEN REQUESTED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE RUBG REAGENT LOT NUMBER WAS 171228. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417141 IGG ANTIBODIES TO RUBELLA VIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ROCHE DIAGNOSTICS NA 171228

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR