BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CD A/B 60 TESTS

    MDR report key: 18580240 · Received January 25, 2024

    Report

    Report Number
    8020790-2024-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    June 30, 2025
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    LLH
    PMA / PMN Number
    K080931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER FROM ARGENTINA WHO RECEIVED THE CDAB POSITIVE CONTROL TOXIN B (C3) VIAL BROKEN IN THE KIT VIDAS CD A/B 60 TESTS (REF.(B)(4), LOT: 1010178630, EXPIRY DATE: 31-MAY-2024). 1. INVESTIGATION OUTCOMES. 1.1. ANALYSIS. THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 1.2. QUALITY CONTROL RECORDS. THERE IS NEITHER CAPA NOR NON-CONFORMITY LINKED TO THIS ISSUE ON THIS VIDAS ASSAY. 1.2. TESTS CONDUCTED BY COMPLAINTS LABORATORY. THE COMPLAINTS LABORATORY OBSERVED THE INTEGRITY OF DIFFERENT VIALS OF STANDARDS AND CONTROLS WITH THE SAME LOT AS THE ONES FROM THE KIT VIDAS C. DIFFICILE TOXIN A & B (CDAB) LOT 1010178630 COMING FROM THE RETAIN KIT AND FROM QUALITY CONTROL LABORATORY (REMAINING VIALS). CONCERNED COMPONENTS: S1 LOT 2251160 EXP 2025-02-14 =1 VIAL. C1 LOT 2251190 EXP 2025-02-14 =1 VIAL. C2 LOT 2251180 EXP 2025-02-14 =1 VIALS. C3 LOT 2251170 EXP 2025-02-14 =10 VIAL. R1 LOT 2239220 EXP 2025-01-09 =1 VIAL. NO ISSUE OBSERVED. 2. CONCLUSION. THE COMPLAINTS LABORATORY HAS NOT REPRODUCED THE CUSTOMER¿S ISSUE DURING THE TEST PERFORMED ON COMPONENTS FROM THE RETAIN KIT OF VIDAS C. DIFFICILE TOXIN A & B (CDAB) LOT 1010178630 AND REMAINING VIALS OF THE SAME LOTS OF CONTROLS. THIS KIND OF ISSUE IS MONITORED BY THE MANUFACTURED SITE. ACCORDING TO THE INVESTIGATION OUTCOMES, THE PERFORMANCE OF THE VIDAS CD A/B 60 TESTS (REF. (B)(4), LOT: 1010178630) IS CONFORM TO THE EXPECTED SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    IN ALIGNMENT WITH THE MOST RECENT FDA GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016", BIOMÉRIEUX IS SUBMITTING THIS NOTIFICATION TO FDA TO INFORM THE AGENCY OF THE DECISION TO CEASE REPORTING SPECIFIC VIDAS® MALFUNCTION EVENTS AFTER TWO YEARS OF NO OCCURRENCES ASSOCIATED WITH DEATH OR SERIOUS INJURY. FOR THE SPECIFIC COMBINATIONS OF PRODUCT AND MALFUNCTION TYPE, CUSTOMER COMPLAINTS WERE REVIEWED OVER A TWO-YEAR PERIOD STARTING FROM THE DATE OF AWARENESS OF THE MOST RECENT EVENT THAT WAS CLASSIFIED AS A SERIOUS INJURY OR DEATH. FOR THE FOLLOWING MALFUNCTION TYPES, THIS REVIEW IDENTIFIED NO ADDITIONAL OCCURRENCES OF BEING ASSOCIATED WITH DEATH OR SERIOUS INJURY FOR TWO YEARS. PRODUCT CODE: LLH. REFERENCE: (B)(4). MALFUNCTION: BREAKAGE OF REAGENT ¿ VIDAS C. DIFFICILE TOXIN A & B. DATE OF AWARENESS FOR SERIOUS INJURY/DEATH: 28MAR2023. FINAL INITIAL MDR SUBMITTED: 8020790-2024-00001. CEASE REPORTING DECISION MDR: 8020790-2024-00001-02. WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR VIDAS PRODUCT CODE LLH AND WILL NO LONGER REPORT THESE MALFUNCTION EVENTS SINCE THEY HAVE NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY IN THE PAST TWO YEARS. MOVING FORWARD, IF BIOMÉRIEUX BECOMES AWARE OF A DEATH OR SERIOUS INJURY EVENT FOR THE PRODUCT CODE LLH WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE AND WILL UPDATE OUR MDR CRITERIA TO REQUIRE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THIS GUIDANCE.

    Description of Event or Problem · 0

    PRODUCT DESCRIPTION: THE VIDAS® C. DIFFICILE TOXIN A & B (CDAB) ASSAY IS AN AUTOMATED TEST FOR USE ON THE VIDAS® FAMILY INSTRUMENTS FOR THE QUALITATIVE DETECTION OF CLOSTRIDIUM DIFFICILE TOXIN A AND TOXIN B IN STOOL SPECIMENS USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THE VIDAS® C. DIFFICILE TOXIN A & TOXIN B (CDAB) ASSAY IS AN AID FOR DIAGNOSING CLOSTRIDIUM DIFFICILE ASSOCIATED DISEASE (CDAD). ISSUE DESCRIPTION: ON (B)(4) 2024, A CUSTOMER FROM ARGENTINA NOTIFIED BIOMÉRIEUX OF RECEIVING THE CDAB POSITIVE CONTROL TOXIN B (C3) VIAL BROKEN IN THE KIT VIDAS CD A/B 60 TESTS (REF. (B)(4), LOT: 1010178630, EXPIRY DATE: 31-MAY-2024). AT THE OPENING OF THE BOX, THE VIAL C3 WAS BROKEN. ACCORDING TO CUSTOMER, THE ISSUE DID NOT CAUSE ANY INJURY TO THE OPERATOR BUT LED TO A DELAY IN DELIVERING PATIENT RESULTS. THE NUMBER OF IMPACTED SAMPLES AND THE DURATION OF THE DELAY WERE NOT SPECIFIED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898403 VIDAS® CD A/B 60 TESTS VIDAS® CD A/B 60 TESTS LLH BIOMÉRIEUX SA 1010178630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown