PANTHER INSTRUMENT

Description of Event or Problem

ON (B)(6) 2018, CUSTOMER, (B)(6), AT (B)(6) CONTACTED TECHNICAL SUPPORT (TS) REGARDING AN INCREASE IN NUMBER OF (B)(6) RESULTS. RESULTS FROM THESE ASSAYS WERE REPORTED TO PHYSICIANS BETWEEN (B)(6) 2018. HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED THE LOGS AND CONFIRMED THE INCREASE IN (B)(6) RESULTS. THE CUSTOMER ACKNOWLEDGED THAT THEY INCORRECTLY INSTALLED SAMPLE SHIELD WHICH LED TO THE CONTAMINATION SEEN IN THE RESULTS. PAS NOTED THAT THERE WERE SEVERAL (B)(6) ACROSS THREE RUNS. SINCE THERE WAS A HIGH PREVALENCE OF (B)(6) RESULTS FOR BOTH THE (B)(4) ASSAYS IN THE THREE ASSAY RUNS, THE INITIAL RUN RESULTS SHOULD HAVE BEEN CONSIDERED SUSPECT. THE CUSTOMER ACKNOWLEDGED THAT THE RESULTS SHOULD NOT HAVE BEEN RELEASED. PER RISK ASSESSMENT, IF THE PATIENT RECEIVED A (B)(6), THE CDC RECOMMENDED TREATMENT FOR THE PATIENT IS ANTIBIOTICS INCLUDING (BUT NOT LIMITED TO) AZITHROMYCIN OR DOXYCYCLINE FOR (B)(6), CEFTRIAXONE AND AZITHROMYCIN FOR (B)(6), AND METRONIDAZOLE OR TINIDAZOLE FOR (B)(6). IF THE PATIENT IS PREGNANT, THE PHYSICIAN IS EXPECTED TO ENSURE THAT THE APPROPRIATE, SAFE ANTIBIOTIC IS ADMINISTERED TO THE PATIENT BASED ON THE NATURE OF THE INFECTION. THE POTENTIAL IMPACT TO THE PATIENT IS INCONVENIENCE, ANXIETY, AND UNNECESSARY ANTIBIOTIC USE. THE RISK OF REPORTING AN INCORRECT STD DIAGNOSTIC RESULT IS CONSIDERED "SERIOUS." THE CUSTOMER RERAN THE SAMPLES FROM THE INITIAL THREE ASSAY RUNS ON A DIFFERENT INSTRUMENT TO RESOLVE THE ISSUE. CUSTOMER INDICATED THAT THE RE-RUN RESULTS WERE WITHIN THE EXPECTED (B)(6) RATE OF THE LAB BUT DID NOT PROVIDE HOLOGIC THE NUMBER OF INCORRECT SAMPLES THAT WERE INITIALLY SENT TO PHYSICIANS. THE CORRECTED RESULTS WERE SENT TO PHYSICIANS ON 09/21/2018. HOLOGIC WILL WORK WITH CUSTOMER TO PROVIDE TRAINING TO CPL OPERATORS ON PROPER SAMPLE SHIELD REPLACEMENT. FURTHER INVESTIGATION INTO THIS ISSUE IS ONGOING.

Description of Event or Problem

THIS IS A SUPPLEMENT AND FINAL REPORT FOR MFR REPORT # 2024800-2018-00011: HOLOGIC PERFORMED AN INVESTIGATION. THE SAMPLE PIPETTOR WAS DESIGNED WITH REQUIREMENTS TO NOT MOVE OVER EXPOSED SPECIMEN TUBES WITH A LOADED TIP AND TO USE MOTION AND FEATURES ON THE SAMPLE BAY COVER TO BREAK MUCUS. AS A RESULT, THE CURRENT SAMPLE PIPETTOR MOVEMENT FOR THE PANTHER INSTRUMENT DOES NOT TRAVEL OVER SAMPLE POSITIONS AFTER SAMPLE HAS BEEN WITHDRAWN INTO THE TIP AND THE HEIGHT OF THE PIPETTOR IS ONLY HIGH ENOUGH TO CLEAR ANY OBSTACLES IN THE SAMPLE BAY WHILE BEING ABLE TO BREAK ANY POTENTIAL MUCUS STRANDS. UNDER THIS DESIGN, ANY MISALIGNMENT OR ALTERING OF THE SAMPLE SHIELD COULD POTENTIALLY INTRODUCE A CONTAMINATION TOUCH POINT. PROCESS CONTROLS ARE IN PLACE WHERE ANY MAJOR MOVEMENT ERRORS ARE DETECTED WOULD INVALIDATE ANY TEST RESULTS. AS A RESULT, WITH THE NEEDED REQUIREMENTS BEING FOLLOWED, AN INCORRECTLY PLACED SAMPLE SHIELD COULD CAUSE HEIGHT CLEARANCE ISSUES FOR THE PIPETTOR AND INTRODUCE A CONTAMINATION TOUCH POINT UNDETECTED BY THE INSTRUMENT NEAR THE EXIT POINT. THERE IS NO NONCONFORMANCE OF HOLOGIC PRODUCT, HOWEVER, HOLOGIC WILL REACH OUT TO THE SUPPLIER OF SAMPLE SHIELD FOR POSSIBLE IMPROVEMENTS TO THE PART.