BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 12005335 · Received June 15, 2021

    Report

    Report Number
    3006948883-2021-00687
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    April 21, 2021
    Report Date
    October 7, 2021
    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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT GRP A STREP 30 TEST VERITOR (MN# 256040), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THE INVESTIGATION COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT GRP A STREP 30 TEST VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT FALSE NEGATIVE RESULTS ON THEIR GRP A STREP KIT. ".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT GRP A STREP 30 TEST VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FALSE NEGATIVE RESULTS ON THEIR GRP A STREP KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894234 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256040 UNKNOWN 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1