BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11724729 · Received April 26, 2021

    Report

    Report Number
    1119779-2021-00715
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 26, 2021
    Report Date
    July 5, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, HOWEVER, MD WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). INVESTIGATION SUMMARY: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WAS OBSERVED BY THE USER. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. NO RETURN SAMPLES WERE RECEIVED BY THE CUSTOMER. NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) (B)(4) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. PATIENT WENT TO ANOTHER FACILITY FOR TESTING AND RESULT WAS NEGATIVE, IT IS UNKNOWN WHAT TYPE OF TESTING WAS PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAD A DISCREPANT RESULTS WHILE USING THE SARS COV-19 TEST KIT. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? 15 SECONDS. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? N/A. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? 15 MINS. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 1 MIN. TEMPERATURE: PLEASE CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME THE REAGENTS WERE KEPT AT THIS TEMPERATURE: ROOM TEMPERATURE. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION): INDOORS. WOULD YOU BE ABLE TO PROVIDE A PHOTO OF CARTRIDGE: NO. WOULD YOU PLEASE PROVIDE A PHOTO OF KIT LABEL: YES. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? N/A. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? N/A. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? N/A. HOW WAS THE SPECIMEN COLLECTED? DID THE OPERATOR FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? NASAL SWAB, DUAL NARES COLLECTION DONE. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? USED THE SWAB THAT COMES WITH THE KIT. WAS ANY TRANSPORT MEDIA USED? N/A. WHAT DATE WAS THE SPECIMEN COLLECTED? (B)(6) 2021. WHAT DATE WAS THE SPECIMEN RUN? (B)(6) 2021. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? ASYMPTOMATIC. HOW WAS IT DETERMINED TO BE DISCREPANT? EMPLOYEE WENT TO REGINA AND GOT RETESTED COMPARISON TO ANOTHER METHOD? N/A. PLEASE PROVIDE THE DETAILS: HOW LONG AFTER VERITOR SPECIMEN SAMPLE COLLECTION WAS THE SECOND SAMPLE COLLECTED FOR USE ON ALTERNATE METHOD? N/A. IF PCR WAS ALTERNATE METHOD USED TO CONFIRM RESULT, WHAT PCR TEST WAS USED? N/A. REPEATED SAMPLE? (SEE BELOW) N/A. HOW DID THE OPERATOR COMPLETE THE REPEAT TEST? NO REPEAT TEST, EMPLOYEE WENT TO REGINA TO BE TESTED. WAS AN ADDITIONAL SWAB COLLECTED? N/A. DID THE OPERATOR PROCESS THE SAME SWAB IN A 2ND REAGENT TUBE? DID THE OPERATOR USE THE LEFTOVER EXTRACTION REAGENT FROM THE REAGENT TUBE ON A NEW CARTRIDGE? N/A. WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? N/A. WAS THE CARTRIDGE VISUALLY READ? N/A. PLEASE PROVIDE THE TOTAL NUMBER OF PRESUMABLE FALSE POSITIVES. N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. PATIENT WENT TO ANOTHER FACILITY FOR TESTING AND RESULT WAS NEGATIVE, IT IS UNKNOWN WHAT TYPE OF TESTING WAS PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAD A DISCREPANT RESULTS WHILE USING THE SARS COV-19 TEST KIT. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? 15 SECONDS. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? N/A. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? 15 MINS. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 1 MIN. TEMPERATURE: PLEASE CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME THE REAGENTS WERE KEPT AT THIS TEMPERATURE: ROOM TEMPERATURE. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION): INDOORS. WOULD YOU BE ABLE TO PROVIDE A PHOTO OF CARTRIDGE: NO. WOULD YOU PLEASE PROVIDE A PHOTO OF KIT LABEL: YES. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? N/A. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? N/A. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? N/A. HOW WAS THE SPECIMEN COLLECTED? DID THE OPERATOR FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? NASAL SWAB, DUAL NARES COLLECTION DONE. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? USED THE SWAB THAT COMES WITH THE KIT. WAS ANY TRANSPORT MEDIA USED? N/A. WHAT DATE WAS THE SPECIMEN COLLECTED? (B)(6) 2021. WHAT DATE WAS THE SPECIMEN RUN? (B)(6) 2021. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? ASYMPTOMATIC. HOW WAS IT DETERMINED TO BE DISCREPANT? EMPLOYEE WENT TO (B)(6) AND GOT RETESTED. COMPARISON TO ANOTHER METHOD? N/A. PLEASE PROVIDE THE DETAILS: HOW LONG AFTER VERITOR SPECIMEN SAMPLE COLLECTION WAS THE SECOND SAMPLE COLLECTED FOR USE ON ALTERNATE METHOD? N/A. IF PCR WAS ALTERNATE METHOD USED TO CONFIRM RESULT, WHAT PCR TEST WAS USED? N/A. REPEATED SAMPLE? (SEE BELOW) N/A. HOW DID THE OPERATOR COMPLETE THE REPEAT TEST? NO REPEAT TEST, EMPLOYEE WENT TO REGINA TO BE TESTED. WAS AN ADDITIONAL SWAB COLLECTED? N/A. DID THE OPERATOR PROCESS THE SAME SWAB IN A 2ND REAGENT TUBE? DID THE OPERATOR USE THE LEFTOVER EXTRACTION REAGENT FROM THE REAGENT TUBE ON A NEW CARTRIDGE? N/A. WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? N/A. WAS THE CARTRIDGE VISUALLY READ? N/A. PLEASE PROVIDE THE TOTAL NUMBER OF PRESUMABLE FALSE POSITIVES. N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622833 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1