BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG

    MDR report key: 10002322 · Received April 27, 2020

    Report

    Report Number
    8020790-2020-00041
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JHI
    PMA / PMN Number
    K921302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN RUSSIA REGARDING FALSE POSITIVE HCG RESULTS FOR THREE (3) SEPARATE PATIENTS (B, C AND D) IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE (B)(4), LOT 1007502730). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER'S MATERIAL. -NO SAMPLE AND NO KIT WERE RECEIVED FOR INVESTIGATION. COMPLAINT TRENDING ANALYSIS. NO RECURRENCE OF THE CUSTOMER'S ISSUE FOR VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 WAS FOUND. STUDY OF BATCH HISTORY RECORD. -THERE IS NO CAPA, NOR NON-CONFORMITY RECORDED ON VIDAS HCG REF (B)(4) LINKED TO CUSTOMER'S ISSUE. -THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS -THE COMPLAINT LABORATORY OBSERVED FOUR (4) INTERNAL SAMPLES ON 5 DIFFERENT BATCHES OF VIDAS HCG REF (B)(4) INCLUDING CUSTOMER'S LOT. HCG7 : TARGET 17.40 MUI/ML ; RANGES [12.42 - 22.38]. HCG9 : TARGET 28.80 MUI/ML ; RANGES [21.60 - 36.00]. HCG16 : TARGET 0.00 MUI /ML ; RANGES <= 2.00. HCG24 : TARGET 0.52 MUI/ML ; RANGES <= 2.24. -THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. -THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED. -THE COMPLAINT LABORATORY TESTED FOUR (4) INTERNAL SERA, SAME AS ABOVE IN CONTROL CHARTS ANALYSIS, WITH RETAIN KIT VIDAS HCG REF 30405 LOT 1007502730/ 200715-0. - ALL INTERNAL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. THERE WAS NO DRIFT OF THE CUSTOMER'S LOT SINCE ITS RELEASE. -THE COMPLAINT LABORATORY TESTED CONTROL C1 WITHOUT SPR AND PERFORMED SPR AND STRIP WITHOUT SAMPLE.THESE TWO (2) ASSAYS GAVE NEGATIVE RESULTS <2 MUI/ML. CONCLUSION. COMPLAINT LABORATORY PERFORMED FOUR (4) INTERNAL SAMPLES, WITH THE RETAIN KIT VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0. THERE WAS NO ANOMALY. ALL INTERNAL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. WITHOUT CUSTOMER'S RETURN SAMPLE AND KIT FURTHER INVESTIGATION CANNOT BE COMPLETED TO DETERMINE A ROOT CAUSE. THOUGH NOT CONFIRMED BY THE CUSTOMER IN THIS CASE, INTERNAL TESTING WITHOUT SPR AND/OR SAMPLE HAS DEMONSTRATED UNDERESTIMATED RESULTS. -ACCORDING THE ABOVE DATA , THE KIT VIDAS HCG REF (B)(4) LOT 1007502730/ 200715-0 WAS WITHIN THE EXPECTED PERFORMANCES. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE HCG RESULTS FOR A PATIENT IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE 30405, LOT 1007502730). A SUMMARY OF TEST RESULTS IS LISTED BELOW 1ST TEST: POSITION A2 RESULT: 757.60 MUI/ML. 2ND TEST: POSITION A1 RESULT: <2 MUI/ML WITH -6 RFV. 3RD TEST: POSITION A1 RESULT: 24.78 MUI/ML. POSITION B1 RESULT: 22.20 MUI/ML. THE CUSTOMER CONFIRMED THE INCORRECT TEST RESULTS WERE PROVIDED TO THE TREATING PHYSICIAN; HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION. NOTE: VIDAS REFERENCE 30405 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES HOWEVER, A SIMILAR INSTRUMENT IS MARKETED IN THE UNITED STATES UNDER REFERENCE NUMBER 30405-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465872 VIDAS HCG VIDAS® HCG JHI BIOMERIEUX SA 1007502730

    Patients

    Seq Age Sex Outcome Treatment
    1