BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12451032 · Received September 9, 2021

    Report

    Report Number
    3006948883-2021-00916
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 14, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR CE (MATERIAL # 256089), BATCH NUMBER 1020841. 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 NUMBER PROVIDED. THE REPORTED WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A PHOTOGRAPH WAS RETURNED AND SHOWED RAPID DETECTION OF SARS-COV-2 VERITOR CE AND UNABLE TO CONFIRM FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR, BUT THE CUSTOMER DID NOT STATE THE RESULT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME. EUA#: EUA(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RESULT SHOWED POSITIVE WITH PINK PATCH, USER WAS CONCERN ABOUT QUALITY ISSUE."

    Additional Manufacturer Narrative · 1

    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 WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR, BUT THE CUSTOMER DID NOT STATE THE RESULT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER AT THIS TIME. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RESULT SHOWED POSITIVE WITH PINK PATCH, USER WAS CONCERN ABOUT QUALITY ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348209 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1020841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown