BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® 3

    MDR report key: 15823128 · Received November 18, 2022

    Report

    Report Number
    9615037-2022-00043
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Report Date
    February 6, 2023
    Manufacturer
    BIOMERIEUX ITALIA S.P.A.
    Product Code
    JJE
    UDI-DI
    03573026380175
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER FROM ISRAEL OF LEAKAGE FROM THE PUMP LEADING TO POSSIBLE OVERESTIMATED RESULTS USING VIDAS® 3 INSTRUMENT (REF. 412590 , SERIAL NUMBER: (B)(6)) WITH PATIENT SAMPLES. 1. IMMEDIATE ACTIONS DONE THE PUMP SUSPECTED TO BE DEFECTIVE WAS REPLACED AND SHIPPED BACK TO BIOMERIEUX MANUFACTURING PLANT FOR INVESTIGATION. A RETROSPECTIVE ANALYSIS OF THE SAMPLES SUSPECTED TO BE IMPACTED BY UNRELIABLE RESULTS WAS REQUESTED. 2. RETROSPECTIVE ANALYSIS DESPITE SEVERAL REMINDERS, CUSTOMER WAS NOT ABLE TO PROVIDE THE RETROSPECTIVE ANALYSIS OF IMPACTED SAMPLES. IT WAS NOT POSSIBLE TO CONFIRM THE FALSE RESULTS DELIVERED BY THE INSTRUMENT. 3. INVESTIGATION THE PUMP SUSPECTED TO BE DEFECTIVE WAS SHIPPED BACK AND RECEIVED AT BIOMERIEUX MANUFACTURING PLANT ON 19 DEC 2022. THE PUMP WAS RECEIVED FREE IN A BOX TOGETHER WITH METALLIC PARTS AND SCREWS. A MOTOR WIRE HAS BEEN FOUND CUT AT THE BODY OF THE MOTOR ITSELF. IN ORDER TO BE ABLE TO TEST THE PUMP, MOTOR WAS REPLACED AND THE PUMP WAS TESTED ON THE MANUFACTURING BENCH ACCORDING TO OUR INTERNAL PROTOCOL, BUT THE SIGNALS PROVIDED BY THE ELECTRONIC BOARD OF THE PUMP WAS NOT READABLE. THE MOST PROBABLE CAUSE IS THAT THE BOARD ITSELF WAS DAMAGE DURING TRANSPORTATION. THE PUMP BOARD WAS REPLACED. AFTER BOARD REPLACEMENT AND TEST REPETITION NO LEAKAGE OR OTHER MALFUNCTIONING OF THE PUMP HAS BEEN DETECTED. UNFORTUNATELY, DUE TO THE CONDITION IN WHICH THE PUMP HAS BEEN RECEIVED, IT HASN'T BEEN POSSIBLE TO TEST THE DEVICE IN ITS ORIGINAL CONDITION. THE TESTS THAT HAVE BEEN PERFORMED AFTER REPLACEMENT OF THE BROKEN PARTS DIDN¿T HIGHLIGHT ANY ISSUE ON THE PUMP. 5. CONCLUSION NO RETROSPECTIVE ANALYSIS WAS DONE BY CUSTOMER, SO IT WAS NOT POSSIBLE TO CONFIRM AND EVALUATE DEVIATIONS IN RESULTS DELIVERED BY THE INSTRUMENT. THE SUSPECTED PUMP WAS SHIPPED BACK TO MANUFACTURING PLANT, BUT THE MOTOR AND THE ELECTRONIC BOARD HAVE BEEN DAMAGED DURING TRANSPORTATION. HENCE THE PUMP COULD NOT BE TESTED IN ITS ORIGINAL CONDITION. FROM THE TEST THAT COULD BE PERFORMED, NO ISSUES WERE IDENTIFIED ON THE PUMP.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER FROM ISRAEL NOTIFIED BIOMÉRIEUX OF LEAKAGE FROM THE PUMP LEADING TO POSSIBLE OVERESTIMATED RESULTS USING VIDAS® 3 INSTRUMENT (REF. 412590, SERIAL NUMBER: (B)(4)) WITH PATIENT SAMPLES. THE CLIENT COMPLAINED OF UNRELIABLE RESULTS ON VIDAS® CMV AVIDITY II (REF. 413557) TESTS IN SECTION C. WHEN THE VIDAS® CMV AVIDITY II (REF. 413557) TEST RAN ON SLOTS C1-C2, PROBLEM WASN¿T NOTICED BUT WHEN VIDAS® CMV AVIDITY II (REF. 413557) TESTS RAN ON SLOTS C2-C3, THEN THE RATIO WAS HIGHER THAN 1, AND THIS MAKES THE SUSPICION THAT THE RESULTS WERE NOT RELIABLE. THE CUSTOMER RUN LEAK TEST WITH QCV STRIPS. THE SLOT 2 IN SECTION C GAVE BAD RESULTS. BY EYE, THE FIELD SERVICE ENGINEER COULD SEE THE DIFFERENCES IN THE LIQUID IN THE STRIP WELLS BETWEEN THE SLOTS. THE INSTRUMENT DID NOT TRIGGER ALARM. THE CUSTOMER SUSPECTS THAT THERE IS A PROBLEM AFTER HE RUN AN AVIDITY TEST AND THE RESULTS WERE ABOVE 1. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 30222 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30222-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229284 VIDAS® 3 VIDAS® 3 JJE BIOMERIEUX ITALIA S.P.A. 412590 03573026380175

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown