BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 16753467 · Received April 17, 2023

    Report

    Report Number
    1119779-2023-00433
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 24, 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

    COMMON DEVICE NAME: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE RESULT WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # (B)(4)), BATCH NUMBER UNKNOWN. CUSTOMER REPORTED THAT THE PATIENT TESTED POSITIVE INITIALLY AT SCHOOL, WAS SENT TO THEIR PHYSICIAN, WHERE THEY THEN TESTED NEGATIVE. 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 COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. NO PHOTOS OR PHYSICAL SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    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. CUSTOMER STATES THEY DO NOT WANT TO PURSUE A SECOND COMPLAINT, AS THERE IS ALREADY ONE THAT IS OPEN - (B)(4). I ASKED THE CUSTOMER IF THEY WOULD LIKE ME TO CLOSE THE COMPLAINT. WAITING FOR THEM TO RESPOND. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): ONE FALSE POSITIVE WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NEGATIVE. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT SAMPLES WERE INVOLVED. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? TBD. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? TBD. CUSTOMER IS REPORTING AN ADDITIONAL FP RESULT. LOT NUMBER IS UNKNOWN. THE PATIENT TESTED POSITIVE INITIALLY AT SCHOOL, WAS SENT TO THEIR PHYSICIAN, WHERE THEY THEN TESTED NEGATIVE.

    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 CUSTOMER STATES THEY DO NOT WANT TO PURSUE A SECOND COMPLAINT, AS THERE IS ALREADY ONE THAT IS OPEN - 1960596. I ASKED THE CUSTOMER IF THEY WOULD LIKE ME TO CLOSE THE COMPLAINT. WAITING FOR THEM TO RESPOND. HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): ONE FALSE POSITIVE 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? POSITIVE 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) NEGATIVE 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PATIENT SAMPLES WERE INVOLVED 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? TBD 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? TBD CUSTOMER IS REPORTING AN ADDITIONAL FP RESULT. LOT NUMBER IS UNKNOWN. THE PATIENT TESTED POSITIVE INITIALLY AT SCHOOL, WAS SENT TO THEIR PHYSICIAN, WHERE THEY THEN TESTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819439 KIT GRP A STREP 30 TEST VERITOR SEE H.10 GTY BECTON, DICKINSON & CO. (SPARKS) 256040 UNKNOWN 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown