BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG

    MDR report key: 10997136 · Received December 12, 2020

    Report

    Report Number
    8020790-2020-00132
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    DHA
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL SUBMISSION HAD THE INCORRECT PRODUCT CODE OF JLW IN SECTION D2B. THE CORRECT PRODUCT CODE IS PRODUCT CODE DHA.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GERMANY REGARDING AN OUT-OF-RANGE-HIGH RESULT IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007820580) WHEN TESTING AN INSTAND EQA SAMPLE. THE CUSTOMER¿S SAMPLES WERE REQUESTED FOR THE INVESTIGATION; HOWEVER, THE SAMPLES WERE NOT AVAILABLE FOR SUBMISSION. NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING, CONTROL, OR PACKAGING PROCESSES FOR VIDAS® HCG LOT 1007820580 / 210102-0. THE COMPLAINTS LABORATORY ANALYZED THE CONTROL CHART RESULTS OF SIX (6) INTERNAL SAMPLES WITH A TARGET WITHIN THE MEASUREMENT RANGE OF VIDAS® HCG, ON SEVEN (7) DIFFERENT BATCHES OF VIDAS® HCG REF 30405 INCLUDING THE CUSTOMER¿S LOT 1007820580 / 210102-0. THE ANALYSIS SHOWED ALL RESULTS WERE WITHIN SPECIFICATIONS, AND THE CUSTOMER¿S LOT WAS IN TREND OF THE OTHER LOTS. TESTING OF INTERNAL SAMPLES WITH VIDAS® HCG 1007820580 / 210102-0 RETAIN KIT OBTAINED RESULTS WITHIN SPECIFICATION. THE RESULTS WERE SIMILAR COMPARED TO THOSE OBTAINED BEFORE THE BATCH RELEASE. THE COMPLAINT LABORATORY TESTED EXTERNAL QUALITY CONTROL PROBIOQUAL ON RETAIN KIT VIDAS® HCG 1007820580 / 210102-0, AND ALSO OBTAINED RESULTS WITHIN EXPECTED RANGES. IN THE ABSENCE OF THE INSTAND SAMPLES SUBMISSION FROM THE CUSTOMER, IT IS IMPOSSIBLE TO PURSUE FURTHER INVESTIGATIONS INTO THE ROOT CAUSE OF THE CUSTOMER¿S RESULTS. IT WAS NOT POSSIBLE TO CHECK IF THE DILUTION MAY HAVE HAD AN IMPACT ON THE RESULTS. BIOMÉRIEUX NEVER RECEIVED ANY INFORMATION FROM INSTAND REGARDING THE BEHAVIOR OF THE QUALITY CONTROL SAMPLES AFTER DILUTION. THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® HCG REF 30405 LOT 1007820580 / 210102-0.

    Description of Event or Problem · 1

    NOTE: REFERENCE 30405 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30405-01. A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OBTAINING AN OUT OF RANGE HIGH RESULTS IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007820580) WHEN TESTING AN INSTAND EQA SAMPLE. THE CUSTOMER TESTED THE SAMPLE IN DUPLICATE USING LOT 1007820580; THE SPECIFIED RANGE AND CUSTOMER RESULTS ARE LISTED BELOW: SAMPLE 31 - EXPECTED RANGE = 53603-99549 MUI/ML. RESULT 1: 106279 MUI/ML ¿ RESULT IS OUT OF RANGE HIGH. RESULT 2: 99136 MUI/ML ¿ RESULT IS WITHIN RANGE. THE CUSTOMER STATED THE SAMPLE WAS TESTED LIKE A PATIENT SAMPLE: WITH A DILUTION SERIES OF 1:10, THEN TESTED WITH A DILUTION EQUIVALENT TO 1:100, USING R1 DILUENT. BIOMERIEUX REQUESTED THE CUSTOMER PERFORMED A QCV TEST; THIS INFORMATION HAS NOT YET BEEN PROVIDED. AS THERE IS NO PATIENT ASSOCIATED WITH THIS EQA STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462163 VIDAS HCG VIDAS® HCG DHA BIOMERIEUX SA 1007820580

    Patients

    Seq Age Sex Outcome Treatment
    1