BD COR¿ MX

Description of Event or Problem

IT WAS REPORTED WHILE USING BD COR MX THERE WERE 5 FALSE POSITIVE RESULTS OUT OF 72 TOTAL SAMPLES. THE 5 SAMPLES WERE POSITIVE DURING INITIAL TESTING BUT THEN WERE NEGATIVE DURING REPEAT TESTING THAT WAS PERFORMED WITHIN THE APPROPRIATE REPEAT TESTING TIME FRAME. IT WAS REPORTED THAT THE 5 SAMPLES HAD INITIAL POSITIVE RESULTS THAT SHOWED VERY LATE AND LOW AMPLIFICATION INDICATIVE OF LOW TARGET LEVEL CLOSE TO THE LIMIT OF DETECTION. THE SAMPLES WERE CONSIDERED TOO CLOSE TO THE LIMIT OF DETECTION TO CONSISTENTLY REPRODUCE THE WEAK POSITIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

D2A. COMMON DEVICE NAMES: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA, TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM, NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TRANSMITTED INFECTIONS D2B. MEDICAL DEVICE TYPES: MKZ, OUY, QEP D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN 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 WHILE USING BD COR MX THERE WERE 5 FALSE POSITIVE RESULTS OUT OF 72 TOTAL SAMPLES. THE 5 SAMPLES WERE POSITIVE DURING INITIAL TESTING BUT THEN WERE NEGATIVE DURING REPEAT TESTING THAT WAS PERFORMED WITHIN THE APPROPRIATE REPEAT TESTING TIME FRAME. IT WAS REPORTED THAT THE 5 SAMPLES HAD INITIAL POSITIVE RESULTS THAT SHOWED VERY LATE AND LOW AMPLIFICATION INDICATIVE OF LOW TARGET LEVEL CLOSE TO THE LIMIT OF DETECTION. THE SAMPLES WERE CONSIDERED TOO CLOSE TO THE LIMIT OF DETECTION TO CONSISTENTLY REPRODUCE THE WEAK POSITIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

Additional Manufacturer Narrative

MANUFACTURE INVESTIGATION SUMMARY: THIS COMPLAINT ALLEGES THE BD COR MX HAD DISCREPANT RESULTS. THE CUSTOMER HAD RECENTLY HAD THE INVENTORY ROBOT REPLACED AND WANTED TO TEST THE REPLACEMENT. THE CUSTOMER REPEATED PREVIOUSLY TESTED SAMPLES AND FIVE SAMPLES THAT WERE PREVIOUSLY POSITIVE NOW WERE NEGATIVE. THE RUN FILES WERE PROVIDED BY THE CUSTOMER AND REVIEWED. BD SERVICE NOTED THAT THE SAMPLES WITH DISCREPANT RESULTS SHOWED VERY LATE AND LOW AMPLIFICATION INDICATIVE OF LOW TARGET THAT WAS CLOSE TO THE LEVEL OF DETECTION. THE SAMPLES WERE CONSIDERED TOO CLOSE TO THE LIMIT OF DETECTION TO CONSISTENTLY REPRODUCE A WEAK POSITIVE RESULT. THE INSTRUMENT WAS VERIFIED TO BE OPERATING TO SPECIFICATION. THIS COMPLAINT IS UNCONFIRMED, AND THE ROOT CAUSE IS UNKNOWN. PHYSICAL SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION HOWEVER, RUN FILES WERE RECEIVED AND REVIEWED. IF PHYSICAL SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FOR MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW REVEALED NO PREVIOUS COMPLAINTS 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.