BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 13361753 · Received January 26, 2022

    Report

    Report Number
    3006948883-2022-00009
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 4, 2022
    Report Date
    March 23, 2022
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBER 1173573. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE KIT GRP A STREP 30 TEST VERITOR HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS 1 FALSE POSITIVE RESULT FROM VER 256040 TEST KIT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE KIT GRP A STREP 30 TEST VERITOR HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS 1 FALSE POSITIVE RESULT FROM VER 256040 TEST KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636313 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256040 1173573 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown