BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VIPER¿ LT SYSTEM

    MDR report key: 17547454 · Received August 14, 2023

    Report

    Report Number
    1119779-2023-00885
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904428396
    PMA / PMN Number
    K140447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDITIONAL PHONE NUMBER IS LISTED AS FOLLOWS: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED: B5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING BD VIPER¿ LT SYSTEM THERE WERE FALSE POSITIVES REPORTED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION DUE TO INSTRUMENT ISSUE WHILE USING CAT 441990 LOT 3132981. DROPPED TIP THAT CAUSE CONTAMINATION AS WELL AS RUN RESULTS SHOWING CONTAMINATED RUN. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT. D1: MEDICAL DEVICE BRAND NAME: BD VIPER¿ LT SYSTEM. D2A: COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS. D2B: MEDICAL DEVICE TYPE OR (PROCODE): OOI. D4. MEDICAL DEVICE CATALOG#: 442839. D4. SERIAL NUMBER: (B)(6). D4. UDI: (B)(4). G5. PMA/510K #: K140447. H6. INVESTIGATION SUMMARY: COMPLAINT REPORTS CONTAMINATION ASSOCIATED WITH VIPER LT (CATALOG NUMBER 442839) SERIAL NUMBER (B)(6). COMPLAINT ALLEGES INSTRUMENT DROPPED TIP CAUSING CONTAMINATION. SERVICE REPLACED THE READER COMPLIANT PAD, O-RING AND TIP ON CHANNEL TWO. SERVICE THEN DECONTAMINATED AND CLEANED INSTRUMENT. SERVICE PERFORMED ENVIRONMENTAL TEST, NO EVIDENCE OF ENVIRONMENTAL CONTAMINATION. POST INTERVENTION THE INSTRUMENT IS OPERATING NORMALLY. ROOT CAUSE ATTRIBUTED TO A FAULTY READER CHANNEL. THIS COMPLAINT IS A CONFIRMED FAILURE OF THE INSTRUMENT BASED ON THE SERVICE INVESTIGATION. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED ON 07/24/2019. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. THERE IS NO CORRECTIVE AND PREVENTATIVE ACTION PLAN IN PLACE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH FAILURE OF "RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD ONCLARITY HPV ASSAY, THERE WAS CONTAMINATION OF ONE BOX OF PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS CONTAMINATION DUE TO INSTRUMENT ISSUE WHILE USING CAT 441990 LOT 3132981."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VIPER¿ LT SYSTEM THERE WERE FALSE POSITIVES REPORTED. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION DUE TO INSTRUMENT ISSUE WHILE USING CAT 441990 LOT 3132981. DROPPED TIP THAT CAUSE CONTAMINATION AS WELL AS RUN RESULTS SHOWING CONTAMINATED RUN. WAS THIS ISSUE INVOLVING PATIENT OR NON-PATIENT SAMPLES (QC, VALIDATION TESTING OR PROFICIENCY SAMPLES)? PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247958 BD VIPER¿ LT SYSTEM INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON DICKINSON & CO. (SPARKS) 3132981 00382904428396
    962567 BD VIPER¿ LT SYSTEM INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON DICKINSON & CO. (SPARKS) 3132981 00382904428396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown