BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 11696083 · Received April 20, 2021

    Report

    Report Number
    3006948883-2021-00406
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 30, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES POSITIVE QC SWAB EXPIRED MATERIAL WHEN USING BD KIT VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 1011283. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE POSITIVE QC SWAB EXPIRED MATERIAL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. RETURNED PRODUCT TESTING COULD NOT BE COMPLETED AS SAMPLES ARE EXPIRED. THERE ARE NO CURRENT TRENDS AGAINST POSITIVE QC SWAB EXPIRED MATERIAL. HOWEVER, THE RETURNED PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMS THE CUSTOMER'S REPORT OF POSITIVE QC SWAB EXPIRED MATERIAL. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 THE EXPIRATION DATE OF THE POSITIVE QC SWAB EXPIRES 2021-04-07, HOWEVER, THE EXPIRATION DATE OF THE KIT IS 2021-06-19 EUA # 201889 IT WAS REPORTED THAT POSITIVE QC SWAB EXPIRES EARLIER THAN THE DATE PRINTED OUTSIDE OF THE CARTON. CUSTOMER STATED IN THE EMAIL THAT SHE NOTICED THE EXPIRY DATE FOR THE POSITIVE QC SWAB EXPIRES ON 4/7/21 BUT THE EXPIRY DATE PRINTED OUTSIDE OF THE CARTON IS 6/19/21. ¿ IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(6) AND (B)(6) ¿ SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): DISTRIBUTOR ¿ IF IT IS A DISTRIBUTOR ¿ WHO IS IT? THERMOFISHER ¿ INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL .

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). 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 · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 THE EXPIRATION DATE OF THE POSITIVE QC SWAB EXPIRES 2021-04-07, HOWEVER, THE EXPIRATION DATE OF THE KIT IS 2021-06-19. EUA # (B)(4). IT WAS REPORTED THAT POSITIVE QC SWAB EXPIRES EARLIER THAN THE DATE PRINTED OUTSIDE OF THE CARTON. CUSTOMER STATED IN THE EMAIL THAT SHE NOTICED THE EXPIRY DATE FOR THE POSITIVE QC SWAB EXPIRES ON 4/7/21 BUT THE EXPIRY DATE PRINTED OUTSIDE OF THE CARTON IS 6/19/21. IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: (B)(4). SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): DISTRIBUTOR. IF IT IS A DISTRIBUTOR ¿ WHO IS IT? THERMOFISHER. INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): CLINICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594831 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1011283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown