BD VIPER¿ SYSTEM, REMANUFACTURED

Description of Event or Problem

IT WAS REPORTED THAT THE BD VIPER¿ SYSTEM, REMANUFACTURED PRODUCED A FALSE POSITIVE RESULT FOR CT. THIS WAS REPORTED TO THE CLINICIANS, BUT THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR ADVERSE PATIENT IMPACT. ASSAYS USED: CT/GC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE HAD RESULT DISCREPANCY ON THE VSP0138, RUN DONE ON THE 18/01/2022." IS THIS AN ISSUE OF FALSE POSITIVE OR FALSE NEGATIVE RESULT? THE RESULT REPORTED WAS FALSE POSITIVE . WHICH ASSAY WAS THIS FOR (CT/ CG/ HPV)? THIS WAS CT/GC ASSAY- CT WAS POSITIVE. WERE INCORRECT RESULTS REPORTED TO THE PHYSICIAN? INCORRECT RESULTS WERE REPORTED TO THE CLINICIAN AND COMPLAINT WAS RAISED. WAS THE PATIENT TREATED BASED OFF ANY INCORRECT RESULT? PATIENT WAS NOT PUT ON TREATMENT, BUT INCIDENT RAISED.

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD VIPER¿ SYSTEM, REMANUFACTURED PRODUCED A FALSE POSITIVE RESULT FOR CT. THIS WAS REPORTED TO THE CLINICIANS, BUT THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR ADVERSE PATIENT IMPACT. ASSAYS USED: CT/GC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE HAD RESULT DISCREPANCY ON THE VSP0138, RUN DONE ON THE 18/01/2022." IS THIS AN ISSUE OF FALSE POSITIVE OR FALSE NEGATIVE RESULT? 1. THE RESULT REPORTED WAS FALSE POSITIVE. WHICH ASSAY WAS THIS FOR (CT/ CG/ HPV)? 2. THIS WAS CT/GC ASSAY- CT WAS POSITIVE. WERE INCORRECT RESULTS REPORTED TO THE PHYSICIAN? 3. INCORRECT RESULTS WERE REPORTED TO THE CLINICIAN AND COMPLAINT WAS RAISED. WAS THE PATIENT TREATED BASED OFF ANY INCORRECT RESULT? 4. PATIENT WAS NOT PUT ON TREATMENT, BUT INCIDENT RAISED.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE VIPER XTR INSTRUMENT (CATALOG NUMBER 442843 AND SERIAL NUMBER (B)(6)) HAD A "FALSE POSITIVE". CUSTOMER REPORTED THAT THEY HAD A DISCREPANCY IN THEIR RESULTS. APPLICATION SPECIALIST VISITED THE SITE AND DETERMINED THAT THERE MIGHT BE A LOW CONCENTRATION OF THE TARGET. APPLICATION SPECIALIST PROVIDED SOME RECOMMENDATION TO THE CUSTOMER SUCH AS INTERSPERSE THE RUN, ENSURE REAGENTS ARE NOT EXPIRED AND ARE STORED PROPERLY, CHECK THAT PARTIALLY USED PLATES ARE PROPERLY STORED IN THEIR BAGS WITH THE DESICCANTS AND ARE SEALED, AND IF THERE ARE OTHER LOTS AVAILABLE TO TRY TO USE THEM TO SEE IF THE ISSUE RESOLVES. 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 A FAILURE AT INSTALL. DEVICE WAS INSTALLED ON 21SEP2015 AND OTHER SERVICE ACTIVITIES HAVE OCCURRED, SUCH AS PREVENTATIVE MAINTENANCE AND REPAIR, WHICH HAVE CHANGED THE CONFIGURATION OF THE INSTRUMENT SINCE RELEASE FROM MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. NO SAMPLES OR PARTS WERE EXPECTED TO BE RETURNED FOR THIS COMPLAINT AND THUS, RETURNED SAMPLE ANALYSIS IS NOT REQUIRED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT IS UNCONFIRMED BY APPLICATION SPECIALIST. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE.