BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 17131127 · Received June 14, 2023

    Report

    Report Number
    3006948883-2023-00044
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    April 28, 2023
    Report Date
    August 25, 2023
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT INVOLVING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBERS 3012042. THE CUSTOMER REPORTED THAT 4 FALSE NEGATIVE RESULTS WERE OBTAINED FROM THE BD VERITOR ANALYZER, AND THE SAMPLES WERE SENT FOR CULTURE TEST AND FOUND TO BE POSITIVE. DURING TROUBLE SHOOTING, THE CUSTOMER CONFIRMED THAT THEY FOLLOWED THE CORRECT WORKFLOW. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE IDENTIFIED. NO PHOTO OR PHYSICAL SAMPLES WERE RETURNED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. CURRENTLY NO ADVERSE TREND FOR FALSE NEGATIVE WAS IDENTIFIED. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    E.7 INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONDED CONFIRMING 4 FNS SHE REPORTED IN HER FOLLOW UP EMAIL, AND NOT THE 10 REPORTED ORIGINALLY. 8. NO ERRONEOUS PATIENT RESULTS WERE REPORTED HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS CUSTOMER REPORTED DISCREPANT RESULTS OBTAINED ON 2 ANALYZERS. NO ERRONEOUS RESULTS WERE REPORTED, THERE IS NO PATIENT IMPACT. THE CORRECT DIAGNOSIS WAS MADE BY AN ALTERNATIVE METHOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THAT THERE WAS A FALSE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RESPONDED CONFIRMING 4 FNS SHE REPORTED IN HER FOLLOW UP EMAIL, AND NOT THE 10 REPORTED ORIGINALLY. 8. NO ERRONEOUS PATIENT RESULTS WERE REPORTED HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS CUSTOMER REPORTED DISCREPANT RESULTS OBTAINED ON 2 ANALYZERS. NO ERRONEOUS RESULTS WERE REPORTED, THERE IS NO PATIENT IMPACT. THE CORRECT DIAGNOSIS WAS MADE BY AN ALTERNATIVE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874562 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256040 3012042 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown