BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG

    MDR report key: 10907521 · Received November 26, 2020

    Report

    Report Number
    8020790-2020-00126
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JLW
    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

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GERMANY REGARDING OUT OF RANGE HIGH HCG RESULTS FOR TWO (2) EXTERNAL QUALITY CONTROL (INSTAND) SAMPLES IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007736840). THE CUSTOMER¿S SAMPLES WERE REQUESTED FOR THE INVESTIGATION; HOWEVER, THE SAMPLES WERE NOT AVAILABLE FOR RETURN. THE CUSTOMER'S BATCH, VIDAS® HCG BATCH 1007736840 / 201105-0, WAS EXPIRED AT THE INVESTIGATION TIME; THEREFORE, THE COMPLAINTS LABORATORY DID NOT PERFORM ANY TESTS ON IT. NO ANOMALIES WERE IDENTIFIED DURING THE MANUFACTURING, CONTROL, OR PACKAGING PROCESSES FOR VIDAS® HCG LOT 1007736840 / 201105-0. 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 1007736840 / 201105-0. THE ANALYSIS SHOWED ALL RESULTS WERE WITHIN SPECIFICATIONS, AND THE CUSTOMER¿S LOT WAS IN TREND OF THE OTHER LOTS. IN THE ABSENCE OF THE INSTAND SAMPLES RETURN, AND THE CUSTOMER¿S VIDAS® HCG BATCH EXPIRED, 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 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 1007736840 / 201105-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING OUT OF RANGE HIGH HCG RESULTS FOR TWO (2) EXTERNAL QUALITY CONTROL (INSTAND) SAMPLES IN ASSOCIATION WITH THE VIDAS® HCG 60 TESTS (REF 30405, LOT 1007736840). GROUP: 306 , SAMPLE 21: EXPECTED RESULT SAMPLE 21: 47369 (33158 - 61580) U/L. CUSTOMER RESULT FOR SAMPLE 21: 68300 U/L. GROUP: 306 , SAMPLE 22: EXPECTED RESULT SAMPLE 22: 70955 (49669 - 92242) U/L. CUSTOMER RESULT FOR SAMPLE 22: 101595 U/L. AS THESE WERE EXTERNAL QUALITY CONTROL SAMPLES, THERE ARE NO PATIENTS 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
    1373631 VIDAS HCG VIDAS® HCG JLW BIOMERIEUX SA 1007736840

    Patients

    Seq Age Sex Outcome Treatment
    1