BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10785717 · Received November 4, 2020

    Report

    Report Number
    3006948883-2020-00688
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 15, 2020
    Report Date
    April 29, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS FOR BATCH NUMBER: 0221748, TESTING OF RETENTION SAMPLES OF BATCH NUMBER: 0221748, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#: 1878253) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED.

    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 A PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT OR ANY REPORT OF PATIENT IMPACT. EUA: (B)(4). (B)(6): ON (B)(6) 2020 15:05:47 (GMT). CUSTOMER PROVIDED LOT NUMBER: LOT#: 0221748. MATERIAL NO: 256082, BATCH NO: 0221748. IT WAS REPORTED THAT ADDITIONAL FALSE POSITIVE RESULT. (B)(6): ON (B)(6) 2020 12:27:45 (GMT). PROCESSING QUESTIONS: 1. HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY THEREAFTER. 2. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? DIRECTLY INTO REAGENT. 3. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY THEREAFTER. 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. - ROOM TEMPERATURE. 6. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION). INDOORS. 7. PLEASE PROVIDE A PHOTO OF THE TEST CARTRIDGE (IF AVAILABLE) NOT AVAILABLE. 8. PLEASE PROVIDE A PHOTO OF THE KIT LABEL (IF AVAILABLE) NOT AVAILABLE. WAS THERE ANY CHANGE OF TREATMENT OR CLINICAL IMPACT AS A RESULT OF THESE FALSE RESULTS? NASOPHARYNGEAL TMA DONE IMMEDIATELY THEREAFTER. CONTACT TRACING TO ENSURE PATIENT SAFETY. ARE YOU WILLING OR ABLE TO RETURN ANY TESTS. NOT WILLING AT THIS TIME. REVIEWED SMAX CASE HISTORY: YES, PREVIOUS FP REPORTED WITH CASE: (B)(4). (B)(6): ON (B)(6) 2020 12:25:29 (GMT). CUSTOMER PROBLEM: CUSTOMER REPORTS 2ND FALSE POSITIVE RESULT IDENTIFIED KIT LOT NUMBER - REF 256082. HOW ARE TEST KITS STORED - PLASTIC BINS IN A TEMPERATURE-CONTROLLED ROOM. WAS QC PERFORMED ON THE LOT AND WAS IT ACCEPTABLE? YES. HOW MANY TEST KITS DID YOU RECEIVE? APPROXIMATELY 600 UNITS. VERITOR PLUS SN: (B)(6). HOW MANY FALSE POSITIVES WERE OBTAINED? 1 NEW. WHAT DATE WERE THESE TESTS PERFORMED? ON (B)(6) 2020. 1. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? PER INSTRUCTIONS. YES. 2. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? BD PROVIDED SWAB. A. WAS ANY TRANSPORT MEDIA USED? (THIS WOULD BE OUTSIDE PI CLAIMS) PRE-FILLED VIAL SOLUTION. 3. WHAT DATE WAS THE SPECIMEN COLLECTED? ON (B)(6) 2020. 4. WHAT DATE WAS THE SPECIMEN RUN? ON (B)(6) 2020. 5. WAS THIS BEING USED AS A SCREENING TEST FOR KNOWN EXPOSURE FOR THESE INDIVIDUALS? NO. 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? NASOPHARYNGEAL TMA SAMPLE COLLECTED IMMEDIATELY THEREAFTER. 7. WAS ANALYZE NOW OR WALKAWAY MODE USED FOR READING? ANALYZE NOW. 8. WERE THE TESTS REPEATED ON THE VERITOR PLUS? IF SO: NO. (B)(6): ON (B)(6) 2020 12:23:49 (GMT). DELAYED COMPLAINT ENTRY DUE TO BACKLOG OF EMAIL SYSTEM. (B)(6): ON (B)(6) 2020 12:22:53 (GMT). CUSTOMER REPORTS ADDITIONAL FALSE POSITIVE RESULT.

    Additional Manufacturer Narrative · 1

    A 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. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS, AND WAS THEREFORE USED OFF LABEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, OR ANY REPORT OF PATIENT IMPACT. (B)(4). (B)(6). CUSTOMER PROVIDED LOT NUMBER: LOT #0221748 MATERIAL NO. 256082; BATCH NO. 0221748. IT WAS REPORTED THAT ADDITIONAL FALSE POSITIVE RESULT. (B)(6): PROCESSING QUESTIONS: HOW LONG AFTER SPECIMEN COLLECTION WAS THE SPECIMEN PROCESSED IN THE EXTRACTION REAGENT? IMMEDIATELY THEREAFTER. HOW WAS THE SPECIMEN STORED BETWEEN COLLECTION AND PROCESSING IN THE EXTRACTION REAGENT? DIRECTLY INTO REAGENT. HOW LONG AFTER PROCESSING IN THE EXTRACTION REAGENT WAS THE SPECIMEN RUN ON THE TEST CARTRIDGE? IMMEDIATELY THEREAFTER. INCUBATION TIME: HOW LONG WAS SAMPLE RUN ON THE CARTRIDGE BEFORE READING? - 15 MINUTES. TEMPERATURE: CLARIFY THE ENVIRONMENT TEMPERATURE AND TIME AT TEMP. - ROOM TEMPERATURE. WAS TESTING PERFORMED INDOORS OR OUTDOORS (NOT COLLECTION). - INDOORS. PLEASE PROVIDE A PHOTO OF THE TEST CARTRIDGE (IF AVAILABLE) - NOT AVAILABLE. PLEASE PROVIDE A PHOTO OF THE KIT LABEL (IF AVAILABLE) - NOT AVAILABLE. WAS THERE ANY CHANGE OF TREATMENT OR CLINICAL IMPACT AS A RESULT OF THESE FALSE RESULTS? NASOPHARYNGEAL TMA DONE IMMEDIATELY THEREAFTER. CONTACT TRACING TO ENSURE PATIENT SAFETY. ARE YOU WILLING OR ABLE TO RETURN ANY TESTS. - NOT WILLING AT THIS TIME. REVIEWED SMAX CASE HISTORY: YES- PREVIOUS FP REPORTED WITH CASE: (B)(4). (B)(6). CUSTOMER PROBLEM: CUSTOMER REPORTS 2ND FALSE POSITIVE RESULT IDENTIFIED KIT LOT NUMBER; (B)(4). HOW ARE TEST KITS STORED - PLASTIC BINS IN A TEMPERATURE-CONTROLLED ROOM. WAS QC PERFORMED ON THE LOT AND WAS IT ACCEPTABLE? YES. HOW MANY TEST KITS DID YOU RECEIVE? APPROXIMATELY 600 UNITS. VERITOR PLUS SN: (B)(4). HOW MANY FALSE POSITIVES WERE OBTAINED? 1 NEW. WHAT DATE WERE THESE TESTS PERFORMED? 10.15.20. HOW WAS THE SPECIMEN COLLECTED? DID IT FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? - PER INSTRUCTIONS. YES. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? - BD PROVIDED SWAB. A. WAS ANY TRANSPORT MEDIA USED? (THIS WOULD BE OUTSIDE PI CLAIMS) - PRE-FILLED VIAL SOLUTION. WHAT DATE WAS THE SPECIMEN COLLECTED? - 10.15.20. WHAT DATE WAS THE SPECIMEN RUN? - 10.15.20 WAS THIS BEING USED AS A SCREENING TEST FOR KNOWN EXPOSURE FOR THESE INDIVIDUALS? - NO. 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? - NASOPHARYNGEAL TMA SAMPLE COLLECTED IMMEDIATELY THEREAFTER. WAS ANALYZE NOW OR WALKAWAY MODE USED FOR READING? - ANALYZE NOW. WERE THE TESTS REPEATED ON THE VERITOR PLUS? IF SO: NO. (B)(6). DELAYED COMPLAINT ENTRY DUE TO BACKLOG OF EMAIL SYSTEM. (B)(6). CUSTOMER REPORTS ADDITIONAL FALSE POSITIVE RESULT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249901 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0221748

    Patients

    Seq Age Sex Outcome Treatment
    1