BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 12856031 · Received November 22, 2021

    Report

    Report Number
    3006948883-2021-01011
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 28, 2021
    Report Date
    January 27, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1193294. MEDICAL DEVICE EXPIRATION DATE: 08/02/2022. DEVICE MANUFACTURE DATE: 07/12/2022. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS AN EMERGENCY USE AUTHORIZATION. (B)(4).

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES 16 OUT OF 30 FALSE POSITIVE RESULTS WHEN USING KIT (RAPID DETECTION OF SARS-COV-2 & FLU A+B (MATERIAL # 256088), BATCH NUMBERS 1197693, 1193294. 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 NUMBERS PROVIDED AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES NOR THE RETURNED SAMPLE TESTS. THE ROOT CAUSE COULD NOT BE IDENTIFIED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD VERITOR ¿ SARS-COV-2 & FLU A+B A SERIES OF FALSE POSITIVES OCCURRED. THERE WERE THREE REPORTED CASES. (B)(4). CONFIRMATORY TESTING WAS PERFORMED BY A DOCTOR. 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: CUSTOMER PROVIDED THE TWO AFFECTED LOT NUMBERS: 256088, LOT # 1197693; 256088, LOT # 1193294. WITH THE NEW REPLACEMENT ANALYZER IN PLACE, THE ISSUE PERSISTS. ANOTHER FLU A POSITIVE AND WERE ASKING THE KITS TO BE TAKEN BACK AND REPLACEMENTS BE SENT OUT. IT WAS REPORTED THAT THERE ARE PERSISTING FLU A FALSE POSITIVES ORIGINALLY, 3 PATIENTS TESTED POS FOR FLU A; THE DOCTOR DOUBTED THESE RESULTS, AND TESTED HIMSELF, TWICE - BOTH RESULTS CAME POSITIVE FOR FLU A. DUE TO CUSTOMER LOSING CONFIDENCE IN VERITOR TESTING, THE ANALYZER S/N (B)(4) WAS REPLACED. THIS INCIDENT WAS DOCUMENTED IN CASE (B)(4). AFTER RECEIVING A REPLACEMENT INSTRUMENT ON TUESDAY, 10/26/2021, CUSTOMER USED A NEW REAGENTS LOT, AND, PER DISTRIBUTOR, "TESTS ARE RESULTING OUT WITH FLU A POSITIVE WHEN USING THE TRIPLEX". VER 256088 PERSISTING FLU A FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD VERITOR ¿ SARS-COV-2 & FLU A+B A SERIES OF FALSE POSITIVES OCCURRED. THERE WERE THREE REPORTED CASES. EUA# (B)(4). CONFIRMATORY TESTING WAS PERFORMED BY A DOCTOR. 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: CUSTOMER PROVIDED THE TWO AFFECTED LOT NUMBERS: 256088 LOT # 1197693; 256088 LOT # 1193294. WITH THE NEW REPLACEMENT ANALYZER IN PLACE, THE ISSUE PERSISTS. ANOTHER FLU A POSITIVE AND WERE ASKING THE KITS TO BE TAKEN BACK AND REPLACEMENTS BE SENT OUT. IT WAS REPORTED THAT THERE ARE PERSISTING FLU A FALSE POSITIVES ORIGINALLY, 3 PATIENTS TESTED POS FOR FLU A; THE DOCTOR DOUBTED THESE RESULTS, AND TESTED HIMSELF, TWICE - BOTH RESULTS CAME POSITIVE FOR FLU A. DUE TO CUSTOMER LOSING CONFIDENCE IN VERITOR TESTING, THE ANALYZER S/N (B)(6) WAS REPLACED. THIS INCIDENT WAS DOCUMENTED IN CASE # (B)(4) . AFTER RECEIVING A REPLACEMENT INSTRUMENT ON TUESDAY, 10/26/2021, CUSTOMER USED A NEW REAGENTS LOT, AND, PER DISTRIBUTOR, "TESTS ARE RESULTING OUT WITH FLU A POSITIVE WHEN USING THE TRIPLEX". VER 256088 PERSISTING FLU A FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755405 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1197693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown