BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11729449 · Received April 26, 2021

    Report

    Report Number
    1119779-2021-00720
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 11, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 0311970. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULTS 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 AND NO RELEVANT ISSUE WAS FOUND. RETENTION SAMPLE TESTING AND RETURNED SAMPLE TESTING WAS NOT DONE BECAUSE THE MATERIAL WAS PAST ITS EXPIRATION DATE. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, MATERIALS PAST EXPIRY WILL NOT BE TESTED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. THE PATIENTS WERE RETESTED ON THE VERITOR AND THE RESULT WAS NEGATIVE. THE CUSTOMER REMOVED AND REINSERTED THE POSITIVE TEST CARTRIDGE TO REPEAT THE TEST AND THE SECOND RESULT WAS NEGATIVE. THE CARTRIDGES ARE SINGLE USE AND SHOULD NOT BE RE-RUN, AS INDICATED IN THE INSTRUCTIONS FOR USE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA#: (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO, AS OF CURRENT DATE 1. HOW WAS THE SPECIMEN COLLECTED? 1 INCH FROM THE EDGE OF THE NOSTRIL, SWAB ROLLED ABOUT 5X ALONG THE MUCOSA INSIDE THE NOSTRILS DID THE OPERATOR FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES 2. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? THE SWAB THAT IS PROVIDED IN THE KITS (STERILE FOAM TIP APPLICATOR) A. WAS ANY TRANSPORT MEDIA USED? NO 3. WHAT DATE WAS THE SPECIMEN COLLECTED? (B)(6), 2021 4. WHAT DATE WAS THE SPECIMEN RUN? (B)(6), 2021 5. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC 6. HOW WAS IT DETERMINED TO BE DISCREPANT? SAME CARTRIDGE WAS GIVING DIFFERENT RESULTS A. COMPARISON TO ANOTHER METHOD? I. PLEASE PROVIDE THE DETAILS: II. HOW LONG AFTER VERITOR SPECIMEN SAMPLE COLLECTION WAS THE SECOND SAMPLE COLLECTED FOR USE ON ALTERNATE METHOD? NO SECOND SAMPLE WAS COLLECTED CUSTOMER EXPERIENCED DISCREPANT RESULTS WHEN RUNNING TESTS".

    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. THE PATIENTS WERE RETESTED ON THE VERITOR AND THE RESULT WAS NEGATIVE. THE CUSTOMER REMOVED AND REINSERTED THE POSITIVE TEST CARTRIDGE TO REPEAT THE TEST AND THE SECOND RESULT WAS NEGATIVE. THE CARTRIDGES ARE SINGLE USE AND SHOULD NOT BE RE-RUN, AS INDICATED IN THE INSTRUCTIONS FOR USE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA#: EUA(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO, AS OF CURRENT DATE. HOW WAS THE SPECIMEN COLLECTED? 1 INCH FROM THE EDGE OF THE NOSTRIL, SWAB ROLLED ABOUT 5X ALONG THE MUCOSA INSIDE THE NOSTRILS. DID THE OPERATOR FOLLOW THE DUAL-NARES COLLECTION METHOD DESCRIBED IN THE QRI? YES. WHAT TYPE OF SWAB WAS USED TO COLLECT THE SPECIMEN? THE SWAB THAT IS PROVIDED IN THE KITS (STERILE FOAM TIP APPLICATOR). WAS ANY TRANSPORT MEDIA USED? NO. WHAT DATE WAS THE SPECIMEN COLLECTED? ON (B)(6) 2021. WHAT DATE WAS THE SPECIMEN RUN? ON (B)(6) 2021. WAS PATIENT SYMPTOMATIC OR ASYMPTOMATIC? SYMPTOMATIC. HOW WAS IT DETERMINED TO BE DISCREPANT? SAME CARTRIDGE WAS GIVING DIFFERENT RESULTS. COMPARISON TO ANOTHER METHOD? PLEASE PROVIDE THE DETAILS: HOW LONG AFTER VERITOR SPECIMEN SAMPLE COLLECTION WAS THE SECOND SAMPLE COLLECTED FOR USE ON ALTERNATE METHOD? NO SECOND SAMPLE WAS COLLECTED. CUSTOMER EXPERIENCED DISCREPANT RESULTS WHEN RUNNING TESTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619952 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0311970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown