BD COR¿ MX

Additional Manufacturer Narrative

THIS COMPLAINT WAS THE RESULT OF A REQUEST FOR INFORMATION FROM THE CUSTOMER. THE CUSTOMER WANTED TO CONFIRM THE RESULT ON THE MX USING THE VAGINAL PANEL ASSAY. A BD FIELD SERVICE ENGINEER WAS DISPATCHED TO REVIEW RUN FILES AND PERFORM HEALTH CHECK. THE SAMPLE WAS REPEATED AND THE RESULTS WERE CONFIRMED USING THE CUSTOMER'S BD MAX INSTRUMENT. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF THE BD COR MX. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. DHR REVIEW WAS CONDUCTED AND THERE WERE NO ABNORMALITIES RELATED TO THIS FAILURE MODE DURING MANUFACTURING ACCEPTANCE TESTING. SERVICE HISTORY REVIEW REVEALED THERE WAS ONE PREVIOUS COMPLAINT FOR THIS ISSUE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE.

Description of Event or Problem

IT WAS REPORTED DURING USE OF BD COR MX INSTRUMENT THERE WAS A FALSE POSITIVE RESULT FOR ALL MM2 TARGETS ON THE COR VAGINAL PANEL ASSAY. CONFIRMATORY TESTING WAS PERFORMED ON BD MAX INSTRUMENT AND INDICATED THAT ONLY ONE TARGET WAS POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

D2B. MKZ, OUY, QEP. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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

IT WAS REPORTED DURING USE OF BD COR MX INSTRUMENT THERE WAS A FALSE POSITIVE RESULT FOR ALL MM2 TARGETS ON THE COR VAGINAL PANEL ASSAY. CONFIRMATORY TESTING WAS PERFORMED ON BD MAX INSTRUMENT AND INDICATED THAT ONLY ONE TARGET WAS POSITIVE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.