BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10755465 · Received October 29, 2020

    Report

    Report Number
    1119779-2020-00820
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 0233975. 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 ISSUE WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1878253 TO FURTHER INVESTIGATE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    MATERIAL NO. 256082 BATCH NO. 0233975 IT WAS REPORTED THAT FALSE POSITIVE. 7. WAS ANALYZE NOW OR WALKAWAY MODE USED FOR READING? - NOW. 8. WERE THE TESTS REPEATED ON THE VERITOR PLUS? IF SO: - YES, PLEASE SEE #6 ABOVE. A. WAS AN ADDITIONAL SWAB COLLECTED? - SEE #6. B. WAS THE SAME SWAB IN A 2ND REAGENT TUBE? WAS THE LEFTOVER EXTRACTION. REAGENT FROM THE REAGENT TUBE ON A NEW CARTRIDGE? ¿ WE USED A NEW SWAB, REAGENT AND TEST STRIP. C. WAS THE CARTRIDGE RERUN (RE-READ)? IF SO, HOW LONG AFTER THE INITIAL RUN WAS THE CARTRIDGE RERUN (RE-READ)? ¿ WE DID NOT RERUN THE INITIAL TEST A SECOND TIME. D. WAS THE CARTRIDGE VISUALLY READ OR READ WITH THE VERITOR? ¿ THE VERITOR. ADDRESS OF FACILITY ¿ 120 4TH STREET NE, STEWARTVILLE MN 55976. KIT LOT NUMBER. - 0233975. HOW ARE TEST KITS STORED? ¿ KITS ARE KEPT IN THE BOXES AND STORED IN A CORNER OF THE (B)(6) OFFICE UNTIL NEEDED FOR USE. WAS QC PERFORMED ON THE LOT AND WAS IT ACCEPTABLE? - YES. HOW MANY TEST KITS DID YOU RECEIVE? - 8. VERITOR PLUS SN: (B)(6) HOW MANY FALSE POSITIVES WERE OBTAINED? - 1. WHAT DATE WERE THESE TESTS PERFORMED? - (B)(6) 2020. 1. HOW WAS THE SPECIMEN COLLECTED? - NASAL SWAB. DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? - YES. 2. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? ¿ THE SWAB INCLUDED IN THE TEST KIT WAS USED. A. WAS ANY TRANSPORT MEDIA USED? (THIS WOULD BE OUTSIDE PI CLAIMS) - NO. 3. WHAT DATE WAS THE SPECIMEN COLLECTED? - (B)(6) 2020. 4. WHAT DATE WAS THE SPECIMEN RUN? ¿ (B)(6) 2020. 5. WAS THIS BEING USED AS A SCREENING TEST FOR KNOWN EXPOSURE FOR THESE INDIVIDUALS? ¿ NO. PERSON HAVING MILD POSSIBLE COVID RELATED SX. 6. HOW LONG AFTER VERITOR SPECIMEN SAMPLE COLLECTION WAS THE SECOND SAMPLE COLLECTED FOR USE ON ALTERNATE METHOD? DO YOU KNOW WHICH PCR TEST WAS USED? - WE DID THIS TEST AND GOT A POSITIVE RESULT AND IMMEDIATELY SWABBED FOR THE PCR. WE THEN RE-TESTED THE PERSON USING THE BIONIXNOW SWAB AND GOT A NEGATIVE RESULT. SO WE DECIDED TO RETEST WITH THE BD VERITOR A SECOND TIME JUST TO BE SURE AND THAT TEST WAS NEGATIVE. WE FOLLOWED UP WITH A SECOND PCR WHICH CONFIRMED THE FALSE POSITIVE RESULTS. PROCESSING QUESTIONS: 1. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? - IMMEDIATELY. 2. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? ¿ IT WASN¿T. 3. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? ¿ AFTER COMPLETING THE SWISHING INTO THE REAGENT FOR ABOUT 60 SECONDS. 4. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? 15 MINUTES 5. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP ¿ 68-72. 6. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION). - INDOORS. 2ND REQUEST FOR INFORMATION- EMAILED 10/23/20 CUSTOMER PROBLEM: FALSE POSITIVE RESULT REPORTED ¿ STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAILED CUSTOMER FOR ADDITIONAL INFORMATION BELOW TBD ASSAY KIT LOT NUMBER (CHECK IF KIT LOT # HAS W AT THE END): SAMPLE COLLECTION: WHAT TYPE OF SAMPLE WAS COLLECTED? WHAT SWAB WAS USED TO COLLECT THE SAMPLE (WAS THE SWAB INCLUDED IN THE KIT USED)? HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? TEST WORKFLOW: HOW LONG WAS THE SAMPLE INCUBATED? HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? RESULTS: IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? ¿ NEXT STEPS (IF NECESSARY): ¿ RESOLUTION ACHIEVED (Y/N)? : ¿ QUANTITY RECEIVED AND QUANTITY AFFECTED: ¿ SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): ¿ IF IT IS A DISTRIBUTOR ¿ WHO IS IT? ¿ PHOTOS OR RETURNS REQUESTED? REPLACEMENTS OR CREDIT REQUESTED: FOLLOW UP REQUIRED (Y/N)? ¿ IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: TIME STAMP (IF APPLICABLE): INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)? : REVIEWED SMAX CASE HISTORY: YES CUSTOMER PROBLEM: FALSE POSITIVE RESULT REPORTED ¿ STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAILED CUSTOMER FOR ADDITIONAL INFORMATION BELOW TBD ASSAY KIT LOT NUMBER (CHECK IF KIT LOT # HAS W AT THE END): SAMPLE COLLECTION: WHAT TYPE OF SAMPLE WAS COLLECTED? WHAT SWAB WAS USED TO COLLECT THE SAMPLE (WAS THE SWAB INCLUDED IN THE KIT USED)? HOW LONG AFTER COLLECTION WAS THE SWAB TESTED? TEST WORKFLOW: HOW LONG WAS THE SAMPLE INCUBATED? HOW MANY DROPS WERE ADDED TO THE SAMPLE WELL ON THE TEST DEVICE? WAS WALK-AWAY MODE USED OR ANALYZE NOW MODE? WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? RESULTS: IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: ON AVERAGE HOW MANY TESTS DO YOU RUN PER WEEK? WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? ¿ NEXT STEPS (IF NECESSARY): ¿ RESOLUTION ACHIEVED (Y/N)? : ¿ QUANTITY RECEIVED AND QUANTITY AFFECTED: ¿ SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): ¿ IF IT IS A DISTRIBUTOR ¿ WHO IS IT? ¿ PHOTOS OR RETURNS REQUESTED? REPLACEMENTS OR CREDIT REQUESTED: FOLLOW UP REQUIRED (Y/N)? ¿ IF CONSUMABLE IS TESTED ON BD INSTRUMENTATION, LIST SERIAL NUMBERS: TIME STAMP (IF APPLICABLE): INDICATION THAT CUSTOMER IS INDUSTRIAL INDU (IF APPLICABLE): IS A LETTER SIGNED BY QUALITY REQUIRED (Y/N)? : REVIEWED SMAX CASE HISTORY: YES

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TESTS WERE DONE USING THE VERITOR AND PCR TEST METHODS AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221431 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0233975

    Patients

    Seq Age Sex Outcome Treatment
    1