BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT RSV 30 TEST PHYSICIAN VERITOR

    MDR report key: 17507412 · Received August 11, 2023

    Report

    Report Number
    3014704491-2023-00444
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 12, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560388
    PMA / PMN Number
    K132456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER WHICH INDICATED THAT THE DEVICE PERFORMED AS INTENDED; THEY ARE NO LONGER ALLEGING ANY DEFECT WITH THE PRODUCT. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THE PREVIOUS MFR REPORT #3014704491-2023-00444 SHOULD BE CONSIDERED CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT RSV 30 TEST PHYSICIAN VERITOR DISCREPANT RESULTS COMPARED TO PCR RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN THE RESULTS OF RAPID RESPIRATORY VIRUS TESTS (RSV AND FLU) VERSUS THE PCR RESULTS PERFORMED BY BD MAX. RAPID TESTS WERE PERFORMED ON NASOPHARYNGEAL SWABS. FOR VSR, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 1294669 AND EXPIRATION DATE: 09-20-2024. FOR FLU, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 2292271 AND EXPIRATION DATE: 10-12-2025. PCR WAS PERFORMED ON NASOPHARYNGEAL ASPIRATES USING THE BD MAX SARS-COV2/FLU KIT, LOT 2270730 AND EXPIRATION DATE: 05-12/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT RSV 30 TEST PHYSICIAN VERITOR DISCREPANT RESULTS COMPARED TO PCR RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN THE RESULTS OF RAPID RESPIRATORY VIRUS TESTS (RSV AND FLU) VERSUS THE PCR RESULTS PERFORMED BY BD MAX. RAPID TESTS WERE PERFORMED ON NASOPHARYNGEAL SWABS. FOR VSR, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 1294669 AND EXPIRATION DATE: 09-20-2024. FOR FLU, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 2292271 AND EXPIRATION DATE: 10-12-2025. PCR WAS PERFORMED ON NASOPHARYNGEAL ASPIRATES USING THE BD MAX SARS-COV2/FLU KIT, LOT 2270730 AND EXPIRATION DATE: 05-12/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073802 KIT RSV 30 TEST PHYSICIAN VERITOR ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1294669 00382902560388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown