BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® HCG

    MDR report key: 8705305 · Received June 17, 2019

    Report

    Report Number
    8020790-2019-00034
    Event Type
    Injury
    Date Received
    June 17, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOMERIEUX,SA
    Product Code
    JHI
    PMA / PMN Number
    K141133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN SPAIN REPORTING A FALSE NEGATIVE HCG RESULT IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE 30405, BATCH 1006940840). THE CUSTOMER STATED THE NEGATIVE RESULT WAS NOT REPRODUCED. CUSTOMER'S RESULTS : ON (B)(6) 2019 : SAMPLE ID (B)(6): -3 RFV < 2MIU/ML - NEGATIVE INTERPRETATION ON (B)(6) 2019 : SAME SAMPLE ID (B)(6): 701 RFV 212.33 MIU/ML - POSITIVE INTERPRETATION, REPETITION OF THE TEST (SAME DAY WITH SAME SAMPLE): 727 RFV , 220.76 MIU/ML - POSITIVE INTERPRETATION. CUSTOMER'S MATERIAL: NO CUSTOMER'S MATERIAL WAS RECEIVED FOR INVESTIGATION. QUALITY CONTROL RECORDS: NO CAPA NOR NON CONFORMITY WAS LINKED TO THE CUSTOMER'S ISSUE RECORDED ON VIDAS HCG REFERENCE 30405 LOT 1006940840 / 191109-0. ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON LOT VIDAS HCG REFERENCE 30405 LOT 1006940840 / 191109-0. STUDY OF INTERNAL SAMPLES CONTROL CHARTS : COMPLAINT LABORATORY OBSERVED 4 INTERNAL SERA (TARGETS 231 - 131 - 316 - 205 MUI/ML) ON 10 LOTS OF VIDAS HCG INCLUDING CUSTOMER'S LOT (191109-0). ALL RESULTS WERE WITHIN SPECIFICATIONS AND CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. COMPLAINT ANALYSIS : NO OTHER COMPLAINT WAS REGISTERED FOR A SIMILAR ISSUE ON VIDAS HCG REFERENCE 30405 LOT 1006940840 / 191109-0. TESTS PERFORMED: COMPLAINT LABORATORY TESTED 3 INTERNAL SAMPLES (TARGETS 231 - 131 - 316 MUI/ML) ON RETAIN KIT VIDAS HCG REFERENCE 30405 LOT 1006940840 / 191109-0. RESULTS WERE WITHIN SPECIFICATIONS AND CLOSE TO THE VALUES OBTAINED BEFORE BATCH RELEASE. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE. COMPLAINT LABORATORY PERFORMED A TEST WITHOUT RECEPTACLE AND ANOTHER TEST WITHOUT SAMPLE TO SIMULATE OPERATOR ERROR, AND REPRODUCED THE CUSTOMER RESULT AT 2<MUI/ML. THE CUSTOMER'S RESULT <2MUI/ML NOT REPRODUCED BY CUSTOMER, COULD BE EXPLAINED BY AN OPERATOR ERROR (MISSING RECEPTACLE OR MISSING SAMPLE) . CONCLUSION: CUSTOMER'S ISSUE WAS REPRODUCED WHEN SIMULATING AN OPERATOR ERROR WHICH IS THE PROBABLE HYPOTHESIS TO EXPLAIN THE FIRST CUSTOMER RESULT <2MUI/ML. AND THEN NOT REPRODUCING THE RESULT. ACCORDING TO ALL THE DATA ABOVE, THE VIDAS HCG REFERENCE 30405 LOT 1006940840 / 191109-0 PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE HCG RESULT IN ASSOCIATION WITH VIDAS® HCG 60 TESTS (REFERENCE 30405, BATCH 1006940840). 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. THE CUSTOMER STATED SUPPORT MEDICATION WAS WITHDRAWN AFTER OBTAINING THE INITIAL HCG NEGATIVE RESULT AND NEGATIVE ULTRASOUND. AFTER STARTING OVARIAN STIMULATION, AN ECHOGRAPH WAS PERFORMED AND A POSSIBLE GESTATION SAC WAS OBSERVED. THE HCG TEST WAS REPEATED AND YIELDED A RESULT OF 5000 MIU/ML. THE CUSTOMER RECOVERED THE PREVIOUS SERUM THAT WAS NEGATIVE AND THEY OBTAINED A RESULT OF 212 MIU/ML. AFTER SEVERAL ULTRASOUND SCANS, IT WAS FOUND THAT THE PREGNANCY WAS NOT EVOLUTIONARY AND WAS DIAGNOSED AS A CLINICAL ABORTION. ALTHOUGH THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY DIRECT NEGATIVE IMPACT TO THE PATIENT'S STATE OF HEALTH, THE TREATING PHYSICIAN DECIDED TO WITHDRAW MEDICATION AFTER THE DISCREPANT VIDAS HCG AND ULTRASOUND RESULTS. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497696 VIDAS® HCG VIDAS® HCG JHI BIOMERIEUX,SA 1006940840

    Patients

    Seq Age Sex Outcome Treatment
    1 Other