BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG 60 TESTS - 30405

    MDR report key: 11569134 · Received March 25, 2021

    Report

    Report Number
    8020790-2021-00059
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JHI
    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

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING AN OUT OF RANGE LOW RESULT FOR AN EXTERNAL QUALITY CONTROL WHEN USING VIDAS® HCG 60 TESTS(REF. 30405, BATCH NUMBER 1007956460, EXPIRY DATE: 04-MAR-2021. NO PRODUCT RETURN WAS REQUESTED FOR THE INVESTIGATION. A REVIEW OF THE BATCH HISTORY RECORDS SHOWED THERE WERE NO ANOMALIES FOUND IN THE QUALITY MONITORING OR DURING THE STAGES OF MANUFACTURING, CONTROL AND PACKAGING OF THE VIDAS HCG REF 30405 LOT 1007956460 / 210304-0. THE ANALYSIS OF THE CONTROL CHARTS PERFORMED ON 4 INTERNAL SAMPLES AND 7 BATCHES VIDAS HCG INCLUDING THE CUSTOMER¿S LOT SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS; CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. THE COMPLAINT LABORATORY COULD NOT PERFORM ANY TESTS ON THE IMPACTED LOT, AS THE VIDAS HCG LOT 1007956460 / 210304-0 WAS EXPIRED. HOWEVER, THE COMPLAINT LABORATORY WAS ABLE TO ANALYZE TWO CONTROLS FROM ANOTHER FRENCH QUALITY CONTROL ( PROBIOQUAL) WITH TWO SAMPLES WITH VALUES CLOSE TO THAT OF THE CUSTOMER. THEY TESTED ONE VIDAS HCG BATCH WITH THESE SAMPLES, AND THE RESULTS WERE CONSISTENT AND RATED "VERY GOOD" BY PROBIOQUAL. THE CUSTOMER APPLIED A CV OF 9% TO ESTABLISH HIS STANDARDS WHEREAS AS SUCH THE COEFFICIENT OF VARIATION APPLIED IS 12% WHICH WOULD HAVE GIVEN STANDARDS OF 3.32-5.41 MUI / ML. THE CUSTOMER¿S VALUE (2.61 MUI / ML) WOULD HAVE BEEN STILL BEEN TOO LOW, BUT WHEN RETESTED IT THE NEXT DAY, THE VALUE OF 3.40 MUI / ML CONFORMED TO THESE STANDARDS. ALL THE VALUES REPORTED FOR THE CONTROL SAMPLE EEQ 41001 BY THE CUSTOMER ARE WITHIN THE EXPECTED RANGE OF THE BIORAD STANDARDS => 2.25-4.08 MUI / ML. SINCE THE VIDAS HCG LOT 1007956460/210304-0 HAS EXPIRED, NO FURTHER INVESTIGATION CAN BE PERFORMED. IN ACCORDANCE WITH THE INVESTIGATION, THE VIDAS HCG 1007956460 / 210304-0 BATCH IS STILL WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A CUSTOMER FROM FRANCE REPORTED AN OUT OF RANGE (LOW) RESULT FOR AN EXTERNAL QUALITY CONTROL WHEN USING VIDAS HCG 60 TESTS (REF. 30405, BATCH NUMBER 1007956460, EXPIRY DATE: 04/03/2021). THE RESULTS OF THE CQI BIORAD (LOT 41001) OBTAINED ARE OUT OF RANGE (TOO LOW) AS FOLLOWS: (B)(6). THE RANGE FOR N1 (LOT 41001) IS BETWEEN [3.58-5.15] MUI/ML (+/- 2 SD). WITH PREVIOUS BATCHES AND A NEW BATCH VIDAS HCG, THE CQI RESULTS WERE COMPLIANT. AS THIS WAS AN EXTERNAL QUALITY CONTROL SAMPLE, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 30405 IS NOT REGISTERED IN THE UNITED STATES. THE U.S SIMILAR DEVICE IS PRODUCT REFERENCE 30405-01 (K141133).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468715 VIDAS HCG 60 TESTS - 30405 VIDAS® HCG 60 TESTS - 30405 JHI BIOMERIEUX SA 1007956460

    Patients

    Seq Age Sex Outcome Treatment
    1