BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 16380956 · Received February 15, 2023

    Report

    Report Number
    1119779-2023-00137
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 8, 2023
    Report Date
    April 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBERS 2266781. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL FALSE POSITIVE 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. QUALITY DID NOT RECEIVE SAMPLES FOR THIS COMPLAINT AND THEREFORE RETURNED SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER A PHOTOGRAPH WAS RETURNED AND SHOWED KIT GRP A STREP 30 TEST VERITOR TEST BOX. BASED ON THE PHOTOGRAPHS COMPLAINT CANNOT BE CONFIRMED. NO RELEVANT ISSUES WERE IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT: IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR THAT A FALSE POSITIVE OCCURRED AND PCR LATER CONFIRMED THESE WERE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVES OCCURRED FOR PATIENTS AND LATER CONFIRMED NEGATIVE BY PCR UNNECESSARY MEDICATION FOR PATIENT WHO DOES NOT REQUIRE THE ANTIBIOTIC MEDICATION FOR FALSE POSITIVE PATIENTS.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. INITIAL REPORTER E-MAIL: (B)(6). 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 KIT GRP A STREP 30 TEST VERITOR THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 FALSE POSITIVE RESULT DETERMINED BY CUSTOMER AFTER PCR TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR THAT A FALSE POSITIVE OCCURRED AND PCR LATER CONFIRMED THESE WERE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSITIVES OCCURRED FOR PATIENTS AND LATER CONFIRMED NEGATIVE BY PCR UNNECESSARY MEDICATION FOR PATIENT WHO DOES NOT REQUIRE THE ANTIBIOTIC MEDICATION FOR FALSE POSITIVE PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 FALSE POSITIVE RESULT DETERMINED BY CUSTOMER AFTER PCR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927190 KIT GRP A STREP 30 TEST VERITOR SEE H.10 GTY BECTON, DICKINSON & CO. (SPARKS) 256040 2266781 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown