BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG II

    MDR report key: 8606427 · Received May 13, 2019

    Report

    Report Number
    8020790-2019-00028
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE POSITIVE RESULT IN ASSOCIATION WITH THE VIDAS® RUB IGG II ASSAY. BATCH HISTORY RECORDS AND TREND ANALYSIS: THERE IS NO OTHER COMPLAINT ON THIS BATCH FOR THE SAME ISSUE. THERE IS NO CAPA, OR NON-CONFORMITY LINKED WITH THE CUSTOMER 'S COMPLAINT. THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT ON FOUR INTERNAL SAMPLE WITH DIFFERENT CONCENTRATIONS, ON SIX BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER. ALL THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS RUB IGG II BATCH 1006971560 / 191126-0 IS IN THE TREND COMPARED TO THE OTHER BATCHES. TESTS PERFORMED: THE CUSTOMER SUBMITTED TWO SAMPLES FOR EVALUATION. THE LABORATORY PERFORMED A CALIBRATION AND TESTED THE TWO SAMPLES WITH RETAINED KIT VIDAS RUB IGG II 1006971560 / 191126-0 ON A VIDAS 3 INSTRUMENT IN AUTOMATIC POSITION. THE TWO RESULTS WERE NEGATIVE = 8 UI/ML. THE LABORATORY PERFORMED TESTS WITH RETAINED KIT VIDAS RUB IGG II 1006984570 / 191126-1 (SAME REAGENTS AND SAME MLE DATA) ON VIDAS 3 IN AUTOMATIC. THE TWO RESULTS WERE NEGATIVE = 9 UI/ML. THE HIGH RESULT (55UI/ML) REPORTED BY THE CUSTOMER WAS NOT REPRODUCED. ANALYSIS OF THE LOGS: NO PROBLEM OR DIFFERENCE BETWEEN ASPIRATIONS PERFORMED BY THE PIPETTOR WERE OBSERVED, CONSIDERING ALL THE SAMPLE POSITIONS, FOR ALL THE RUB IGG II ANALYSIS DONE BETWEEN MARCH 26 AND APRIL 17. NO PROBLEM OR DIFFERENCE BETWEEN ASPIRATIONS AND DISPENSATIONS PERFORMED BY THE SECTION PUMPS WERE OBSERVED, FOR ALL THE RUB IGG II ANALYSIS DONE BETWEEN MARCH 26 AND APRIL 24. CONCLUSION: THE INVESTIGATION DID NOT REPRODUCED THE CUSTOMER'S ANOMALY. THE MOST PROBABLY HYPOTHESIS IS A PREANALYTICAL ISSUE DURING THE FIRST TEST AS THIS RESULT DID NOT MATCH WITH OTHER NEGATIVE RESULTS. ACCORDING TO THE INVESTIGATION RESULTS, VIDAS RUB IGG II 1006971560 / 191126-0 PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE POSITIVE RESULT IN ASSOCIATION WITH THE VIDAS® RUB IGG II ASSAY. THE CUSTOMER REPORTED THAT ON (B)(6) 2019, THE ISOLATE WAS FIRST TESTED ON DXI (BECKMAN) AND WAS NEGATIVE (9.28 UI/). USING THE VIDAS 3 INSTRUMENT, THE ISOLATE WAS FIRST RUN IN POSITION D1 AND THE RESULT WAS POSITIVE (55 UI/ML). THE REPEAT TEST WAS IN POSITION A1 AND THE RESULT WAS NEGATIVE (8 UI/ML). A RETEST ON DXI GAVE A NEGATIVE RESULT (9.84 UI/ML). THE CUSTOMER REPORTED THAT NO WRONG RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399355 VIDAS® RUB IGG II VIDAS® RUB IGG II LFX BIOMERIEUX SA 1006984570

    Patients

    Seq Age Sex Outcome Treatment
    1