TIGRIS INSTRUMENT SYS-CD

Description of Event or Problem

THE CUSTOMER REPORTED TO HOLOGIC, ON (B)(6) 2019, A FAILED (B)(6) ASSAY RUN ON THE TIGRIS PLATFORM (TIGRIS SN: (B)(4)). THE FAILED (B)(6) RUN OCCURRED ON (B)(6) 2019. PRIOR TO THE FAILED (B)(6) RUN, THE CUSTOMER ALSO INDICATED THAT THEY OBTAINED A FAILED AC2 RUN ON THE SAME INSTRUMENT ON (B)(6) 2019. A REQUEST FOR THE CUSTOMER'S LOGS WERE SUBMITTED TO HOLOGIC FOR REVIEW, ON (B)(6) 2019. THE CUSTOMER CONTINUED TO RUN THE AFFECTED INSTRUMENT, DURING THAT TIME SPAN. ON (B)(6) 2019, HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED THE LOGS AND NOTED THAT THERE APPEARED TO BE CARRYOVER CONTAMINATION FROM SAMPLE TUBE TO SAMPLE TUBE. ON (B)(6) 2019, THE CUSTOMER CONTACTED TS TO INDICATE THEY WERE SEEING AN INCREASE IN POSITIVITY ON THE AFFECTED TIGRIS INSTRUMENT. ON (B)(4) 2019, THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SERVICE THE SAMPLE PIPETTOR MISALIGNMENT. ON THE (B)(4) 2019, THE FSE RETURNED TO SERVICE A DROPPED TIP ERROR ON THE SAME INSTRUMENT AND FOUND THE SCREW CENTERING THE DITI (DISPOSABLE TIP) ASSEMBLY TO THE PIPETTOR Z-RACK WAS LOOSE. THE LOOSENED DITI ASSEMBLY ON THE SAMPLE PIPETTOR ARM MAY HAVE CONTRIBUTED TO SAMPLE CARRYOVER CONTAMINATION POTENTIALLY CAUSING AN INCREASED RATE OF (B)(6) RESULTS. THE FSE ALIGNED AND FIXED THE DITI ASSEMBLY. THE SPECIMEN PIPETTOR OPERATIONAL QUALIFICATION WAS PERFORMED AND PASSED, AND THE INSTRUMENT WAS RETURNED TO SERVICE. HOLOGIC REQUESTED ADDITIONAL LOGS FOR THE AFFECTED TIGRIS INSTRUMENT FROM THE MONTH OF (B)(6) 2019. PAS REVIEW OF THE LOGS BETWEEN (B)(6) 2019 - (B)(6) 2019 AND INDICATED THAT THERE WERE INSTANCES OF (B)(6) RESULT GROUPINGS, WHICH COULD INDICATE CROSS CONTAMINATION. HOLOGIC COULD NOT CONFIRM WHEN THE ISSUE STARTED, AND HOLOGIC INDICATED THAT THE CUSTOMER SHOULD RETEST ALL (B)(6) RESULTS FROM THE INSTRUMENT DURING THE TIME PERIOD IN QUESTION. HOWEVER, THE CUSTOMER INDICATED THEY ONLY HOLD SAMPLES FOR TWO WEEKS. FURTHERMORE, THE CUSTOMER REQUESTED LOG REVIEW FOR ALL TIGRIS (18) AND PANTHER (4) SYSTEMS (22 INSTRUMENTS TOTAL) FROM THEIR SITE TO CONFIRM THAT THE SAME CARRYOVER ISSUE DOES NOT CURRENTLY EXIST. LOGS WERE RETRIEVED FOR HOLOGIC REVIEW FROM VARIOUS DAYS IN (B)(6) 2019 FROM EACH INSTRUMENT. ALL RUNS WERE REVIEWED FOR POTENTIAL CARRYOVER. BASED ON THE REVIEW OF THE LOGS FROM THESE INSTRUMENTS, THERE WERE NO IDENTIFIED ISSUES. ALL THE TIGRIS AND PANTHERS INSTRUMENTS WERE CLEARED AND RELEASED TO THE CUSTOMER ON (B)(6) 2019. INVESTIGATION TO IDENTIFY THE ROOT CAUSE IS ONGOING.

Additional Manufacturer Narrative

FINAL MDR: HOLOGIC FIELD SERVICE ENGINEER FURTHER EVALUATED THIS ISSUE TO DETERMINE THE ROOT CAUSE. HOWEVER, THE EXACT ROOT CAUSE AS TO WHY THE DISPOSABLE TIP CONE TO THE PIPETTOR Z-RACK BECAME LOOSE, COULD NOT BE DETERMINED.

Description of Event or Problem

THIS IS THE FINAL REPORT. SEE SECTION 10 FOR DETAILS. THE CUSTOMER REPORTED TO HOLOGIC, ON (B)(6) 2019, A FAILED APTIMA TRICHOMONAS VAGINALIS (ATV) ASSAY RUN ON THE TIGRIS PLATFORM (TIGRIS SN: (B)(6)). THE FAILED ATV RUN OCCURRED ON (B)(6) 2019. PRIOR TO THE FAILED ATV RUN, THE CUSTOMER ALSO INDICATED THAT THEY OBTAINED A FAILED AC2 RUN ON THE SAME INSTRUMENT ON (B)(6) 2019. A REQUEST FOR THE CUSTOMER'S LOGS WERE SUBMITTED TO HOLOGIC FOR REVIEW, ON 11/27/2019. THE CUSTOMER CONTINUED TO RUN THE AFFECTED INSTRUMENT, DURING THAT TIME SPAN. ON 11/27/2019, HOLOGIC PRODUCT APPLICATIONS SPECIALIST (PAS) REVIEWED THE LOGS AND NOTED THAT THERE APPEARED TO BE CARRYOVER CONTAMINATION FROM SAMPLE TUBE TO SAMPLE TUBE. ON 11/28/2019, THE CUSTOMER CONTACTED TS TO INDICATE THEY WERE SEEING AN INCREASE IN POSITIVITY ON THE AFFECTED TIGRIS INSTRUMENTS. ON 11/29/2019, THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SERVICE THE SAMPLE PIPETTOR MISALIGNMENT. ON THE 12/02/2019, THE FSE RETURNED TO SERVICE A DROPPED TIP ERROR ON THE SAME INSTRUMENT AND FOUND THE SCREW CENTERING THE DITI (DISPOSABLE TIP) ASSEMBLY TO THE PIPETTOR Z-RACK WAS LOOSE. THE LOOSENED DITI ASSEMBLY ON THE SAMPLE PIPETTOR ARM MAY HAVE CONTRIBUTED TO SAMPLE CARRYOVER CONTAMINATION POTENTIALLY CAUSING AN INCREASED RATE OF POSITIVE ATV RESULTS. THE FSE ALIGNED AND FIXED THE DITI ASSEMBLY. THE SPECIMEN PIPETTOR OPERATIONAL QUALIFICATION WAS PERFORMED AND PASSED, AND THE INSTRUMENT WAS RETURNED TO SERVICE. HOLOGIC REQUESTED ADDITIONAL LOGS FOR THE AFFECTED TIGRIS INSTRUMENT FROM THE MONTH OF NOVEMBER 2019. PAS REVIEW OF THE LOGS BETWEEN (B)(6) 2019 - (B)(6) 2019 AND INDICATED THAT THERE WERE INSTANCES OF ATV POSITIVE RESULT GROUPINGS, WHICH COULD INDICATE CROSS CONTAMINATION. HOLOGIC COULD NOT CONFIRM WHEN THE ISSUE STARTED, AND HOLOGIC INDICATED THAT THE CUSTOMER SHOULD RETEST ALL POSITIVE RESULTS FROM THE INSTRUMENT DURING THE TIME PERIOD IN QUESTION. HOWEVER, THE CUSTOMER INDICATED THEY ONLY HOLD SAMPLES FOR TWO WEEKS. FURTHERMORE, THE CUSTOMER REQUESTED LOG REVIEW FOR ALL TIGRIS (18) AND PANTHER (4) SYSTEMS (22 INSTRUMENTS TOTAL) FROM THEIR SITE TO CONFIRM THAT THE SAME CARRYOVER ISSUE DOES NOT CURRENTLY EXIST. LOGS WERE RETRIEVED FOR HOLOGIC REVIEW FROM VARIOUS DAYS IN DECEMBER 2019 FROM EACH INSTRUMENT. ALL RUNS WERE REVIEWED FOR POTENTIAL CARRYOVER. BASED ON THE REVIEW OF THE LOGS FROM THESE INSTRUMENTS, THERE WERE NO IDENTIFIED ISSUES. ALL THE TIGRIS AND PANTHERS INSTRUMENTS WERE CLEARED AND RELEASED TO THE CUSTOMER ON (B)(6) 2019.