BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 11807301 · Received May 11, 2021

    Report

    Report Number
    1119779-2021-00810
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 20, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 (MATERIAL # 256082 ), BATCH NUMBER 1061454. 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 WAS PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1878253 TO FURTHER INVESTIGATE.BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    (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 · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER OBTAINED 2 FALSE POSITIVE RESULT IN THE SARS-COV 2 ASSAY 256082, CONFIRMED AGAINST PCR.. WHAT TYPE OF SAMPLE WAS COLLECTED? DUAL NASAL. WHAT SWAB WAS USED TO COLLECT THE SAMPLE (WAS THE SWAB INCLUDED IN THE KIT USED)? IN THE KIT. HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? 3 SECONDS. TEST WORKFLOW: HOW LONG WAS THE SAMPLE INCUBATED? 15 MIN. HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY. MODE USED OR ANALYZE NOW MODE? 3 DROPS. ANALYZE NOW . WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? QC PASSED. RESULTS: IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE. DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? ANALYZER. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? RAPID PCR. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 2 FP. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? WERE PATIENTS SYMPTOMATIC OR ASYMPTOMATIC? ASYMPTOMATIC. SCREENING TEST ¿ NO KNOWN EXPOSURE? NO. SCREENING TEST - KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? NO. ASYMPTOMATIC BUT DR RECOMMENDED TESTING? YES. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER OBTAINED 2 FALSE POSITIVE RESULT IN THE SARS-COV 2 ASSAY 256082, CONFIRMED AGAINST PCR.. ¿ WHAT TYPE OF SAMPLE WAS COLLECTED? DUAL NASAL ¿ WHAT SWAB WAS USED TO COLLECT THE SAMPLE (WAS THE SWAB INCLUDED IN THE KIT USED)? IN THE KIT ¿ HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? 3 SECONDS TEST WORKFLOW: ¿ HOW LONG WAS THE SAMPLE INCUBATED? 15 MIN ¿ HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? 3 DROPS. ANALYZE NOW . ¿ WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? QC PASSED RESULTS: ¿ IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE ¿ DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? ANALYZER ¿ WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? RAPID PCR ¿ HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 2 FP ¿ WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: ¿ WERE PATIENTS SYMPTOMATIC OR ASYMPTOMATIC? ASYMPTOMATIC ¿ SCREENING TEST ¿ NO KNOWN EXPOSURE? NO ¿ SCREENING TEST - KNOWN EXPOSURE THAT IS CURRENTLY ASYMPTOMATIC? NO ¿ ASYMPTOMATIC BUT DR RECOMMENDED TESTING? YES ¿ WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703285 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1061454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown