BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGG ANTIBODIES TO RUBELLA VIRUS

    MDR report key: 4996684 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03958
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 22, 2015
    Report Date
    October 6, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K072617
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS OF QUALITY CONTROL RELEASE DATA HAVE CONFIRMED THAT RECOVERY WITH KIT LOT 185927 IS SLIGHTLY HIGHER WHEN COMPARED TO KIT LOT 182963. HOWEVER, THE RECOVERY IS WITHIN SPECIFICATIONS FOR BOTH REAGENT LOTS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT SAMPLES WITH A CONCENTRATION CLOSE TO THE CUT-OFF MAY GIVE DIFFERENT QUALITATIVE RESULTS, NON-REACTIVE VERSUS REACTIVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SAW AN IMPLAUSIBLE SHIFT UP IN PATIENT RESULTS WHEN SWITCHING FROM IGG ANTIBODIES TO RUBELLA VIRUS (RUBELLA IGG) REAGENT LOT NUMBER 182963 TO LOT NUMBER 185927. MONITORING THE TWO AFFECTED PATIENTS OVER TIME REVEALED THE UP-SHIFT OF RUBELLA IGG VALUES. THE RESULTS FOR TWO PATIENT SAMPLES WERE PROVIDED AND RESULTS FROM REAGENT LOT NUMBER 185927 WERE CONSIDERED TO BE ERRONEOUS (FALSELY POSITIVE).THE RESULTS FOR EACH PATIENT WERE REPORTED OUTSIDE OF THE LABORATORY AND EACH PATIENT'S PHYSICIAN QUESTIONED THE UP-SHIFT IN RESULTS. THE FIRST PATIENT SAMPLE INITIALLY RESULTED AS 9.15 IU/ML WITH REAGENT LOT NUMBER 182963. THE SAMPLE WAS REPEATED WITH REAGENT LOT NUMBER 185927 AND RESULTED AS 15.99 IU/ML. THE SECOND PATIENT SAMPLE INITIALLY RESULTED AS 9.49 IU/ML WITH REAGENT LOT NUMBER 182963. THE SAMPLE WAS REPEATED WITH REAGENT LOT NUMBER 185927 AND RESULTED AS 11.68 IU/ML. THE SAMPLE WAS ALSO REPEATED A SECOND TIME WITH REAGENT LOT NUMBER 185927 AND RESULTED AS 11.87 IU/ML. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SAMPLES WERE TESTED ON AND E602 MODULE ANALYZER SERIAL NUMBER (B)(4). CONTROL RECOVERY FOR EACH LOT NUMBER WAS FOUND TO BE WITHIN EXPECTED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531525 IGG ANTIBODIES TO RUBELLA VIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ROCHE DIAGNOSTICS NA 185927

    Patients

    Seq Age Sex Outcome Treatment
    1