BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGG ANTIBODIES TO RUBELLA VIRUS

    MDR report key: 3891983 · Received June 24, 2014

    Report

    Report Number
    1823260-2014-04629
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K072617
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDED PATIENT SAMPLE WAS INVESTIGATED USING RECOM BLOT RUBELLA (MIKROGEN) IGG, PLATELIA RUBELLA IGG, AND WITH A MODIFIED ELECSYS RUBELLA IGG ASSAY. THE BLOT WAS CLEARLY REACTIVE (POSITIVE) WITH STRONG BANDS FOR E1 AND E2. THE BLOT WAS ALSO ADDITIONALLY REACTIVE FOR E1-E2 CORE REACTIVITY. THE PATELLA RUBELLA IGG ASSAY WAS ALSO CLEARLY REACTIVE (POSITIVE). THE SAMPLE WAS FOUND TO BE ENHANCED, BUT STILL NEGATIVE IN ELECSYS RUBELLA IGG. A FINAL INVESTIGATION WAS PERFORMED TO SEE WHICH "MODULE" OF THE ELECSYS ASSAY MAINLY CONTRIBUTES TO THIS WEAK BUT CLEARLY EVIDENT REACTIVITY. THE EXPERIMENT USED THE RECOMBINANT ENVELOPE ANTIGENS ONLY FOR THE DETECTION OF RUBELLA IGG (RUB LIKE PARTICLES RLP WERE LEFT OUT) AND THE RESULT WAS COMPARED TO THE REGULAR/ORIGINAL ELECSYS RUBELLA IGG ASSAY (=REFERENCE). FROM THIS EXPERIMENT IT IS QUITE OBVIOUS THAT THE MAIN REACTIVITY IS PROVIDED BY THE E1 ANTIGENS AS THERE IS STILL A SIGNAL OF 4449 COUNTS LEFT FROM 6801 COUNTS IN THE REFERENCE. HOWEVER, IN THIS CASE E1 DOES NOT CONTRIBUTE ENOUGH SIGNAL TO MAKE THIS SAMPLE REACTIVE. THE PACKAGE INSERT STATES "A TEST RESULT < 10 IU/ML DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF AN ACUTE RUBELLA INFECTION. SPECIMENS TAKEN VERY EARLY IN THE ACUTE PHASE OF INFECTION MAY NOT CONTAIN ANY DETECTABLE AMOUNTS OF RUBELLA IGG ANTIBODIES OR MAY HAVE AN ANTIBODY CONCENTRATION < 10 IU/ML.".

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE REAGENT CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE COULD NOT BE VERIFIED SINCE THE CUSTOMER HAS DELETED THE DATA FROM THE INSTRUMENT DATABASE. REFERENCE THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DATA RELATED TO THE (B)(4) LABORATORY SITE USING RUBELLA IGG REAGENT LOT NUMBER 175636. REFERENCE THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DATA RELATED TO THE (B)(4) LABORATORY SITE USING RUBELLA IGG REAGENT LOT 174658.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED FOR IGG ANTIBODIES TO RUBELLA VIRUS (RUBELLA IGG). THE INITIAL NEGATIVE RESULTS FROM THE SAMPLE WERE REPORTED OUTSIDE OF THE LABORATORY. THE EVENT OCCURRED AT MULTIPLE SITES USING MULTIPLE RUBELLA IGG REAGENT LOT NUMBERS. THE FIRST SITE IS (B)(4) LABORATORY USING RUBELLA IGG REAGENT LOT NUMBER 175636. THE SECOND SITE IS (B)(4) LABORATORY AND IT WAS ASKED, BUT NOT KNOWN WHICH RUBELLA IGG REAGENT LOT NUMBER WAS USED AT THIS SITE. THE THIRD SITE IS (B)(4) LABORATORY USING RUBELLA IGG REAGENT LOT 174658. IT WAS ASKED, BUT THE EXPIRATION DATES FOR EACH LOT NUMBER WERE NOT PROVIDED. THIS MEDWATCH IS FOR THE (B)(4) LABORATORY SITE USING AND UNKNOWN RUBELLA IGG REAGENT LOT NUMBER. THE FIRST SAMPLE WAS INITIALLY TESTED AT THE (B)(4) SITE ON (B)(6) 2014 AND RESULTED AS 3.36 IU/ML WHICH IS CONSIDERED TO BE A NEGATIVE RESULT. THE SAMPLE WAS SENT TO A DIFFERENT LABORATORY ((B)(4) LABORATORY) FOR CONFIRMATION. THE CONFIRMATION TESTING WAS PERFORMED ON AN E601 ANALYZER ON (B)(6) 2014 AND RESULTED AS 5.0 IU/ML WHICH IS ALSO CONSIDERED TO BE A NEGATIVE RESULT. THE SAMPLE WAS REPEATED AT A DIFFERENT LABORATORY ((B)(4) LABORATORY) WHERE IT WAS TESTED USING THE LIAISON METHOD ON (B)(6) 2014, RESULTING AS 22.9 IU/ML WHICH IS CONSIDERED TO BE A (B)(6) RESULT. A VALUE OF 48.5 WAS ALSO OBTAINED AT THE (B)(4) LABORATORY FOR THIS SAMPLE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE 48.5 VALUE WAS AN ACTUAL RESULT FROM THE SAME SAMPLE, IT IS NOT KNOWN WHAT UNIT OF MEASURE IS USED FOR THIS VALUE, AND IT IS NOT KNOWN WHAT METHODOLOGY WAS USED TO OBTAIN THIS VALUE. THE SAMPLE WAS ALSO TESTED AT A DIFFERENT SITE ((B)(4)) USING A VIDAS METHOD ON (B)(6) 2014, WHERE IT RESULTED AS 40 IU/ML. THE RUBELLA IGG AVIDITY WAS ALSO TESTED AT (B)(4) ON (B)(6) 2014, RESULTING AS 0.7 AI WHICH IS CONSIDERED HIGH. THE DOCTOR OF THE PATIENT OBJECTED TO THE RESULT FROM THE ROCHE METHOD, SO A SAMPLE WAS SENT FOR TESTING USING A COMPETITOR METHOD. A SECOND SAMPLE FROM THE PATIENT WAS TESTED AT THE (B)(4) LABORATORY USING A COMPETITOR SYSTEM (ELFA METHOD) ON (B)(6) 2014 AND THIS RESULTED AS 32 IU/ML WHICH IS CONSIDERED TO BE POSITIVE. THE SAMPLE WAS REPEATED ON (B)(6) 2014 AT ANOTHER LABORATORY ((B)(4) LABORATORY) ON AN E601 ANALYZER, RESULTING AS 4.62 IU/ML WHICH IS CONSIDERED TO BE NEGATIVE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E601 ANALYZER SERIAL NUMBER AT THE (B)(4) LABORATORY SITE WAS ASKED FOR, BUT NOT PROVIDED. A SAMPLE FROM THE PATIENT WAS PROVIDED AND TESTED USING RETENTION MATERIALS. THE SAMPLE RESULT MEASURED INTERNALLY REPRODUCES THE CUSTOMER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368845 IGG ANTIBODIES TO RUBELLA VIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR IRON SUPPLEMENT| FOLIC ACID SUPPLEMENT