D
Patient 1
CUSTOMER, (B)(6) HOSPITAL, CONTACTED HOLOGIC ON (B)(6) 2018 TO REPORT THAT THEY HAD A CAP PIERCE FAILURE (CPF) FLAG DUE TO SAMPLE PIPETTOR ERROR WHICH INVALIDATED AN APTIMA COMBO 2 (AC2) RUN (B)(4). THE CUSTOMER ACKNOWLEDGED THAT THE OPERATOR WAS NEW AND DID NOT INSTALL THE SAMPLE SHIELD PROPERLY. AFTER THE CUSTOMER CORRECTLY REINSTALLED THE SAMPLE SHIELD, THE INSTRUMENT PROCESSED WITHOUT ANY ERRORS. PATIENT RESULTS FOR THE INITIAL RUN WERE NOT IMPACTED BECAUSE THE RUN WAS INVALIDATED. ON (B)(6) 2018, THE CUSTOMER CONTACTED HOLOGIC AGAIN (B)(4) TO REPORT AN INCREASED NUMBER OF CT AND GC POSITIVE RESULTS ON AN AC2 RUN, WHICH WAS RELATED TO THE SAMPLE SHIELD NOT SEATED PROPERLY. THE OPERATOR WHO INSTALLED THE SAMPLE SHIELD FOR THIS RUN WAS THE SAME OPERATOR WHO INSTALLED THE SAMPLE SHIELD ON (B)(6) 2018. RUN. HOLOGIC RECOMMENDED THE CUSTOMER TO CHANGE THE SAMPLE SHIELD AND RERUN THE ASSAYS. SINCE THERE WAS A HIGH PREVALENCE OF POSITIVE RESULTS FOR THE AC2 ASSAYS, THE INITIAL RUN RESULTS WERE SUSPECT. THE CUSTOMER HAS STATED THAT THIS OPERATOR WILL UNDERGO ADDITIONAL TRAINING AND HAS ALSO IMPLEMENTED A CHARGE PERSON WHO WILL BE REVIEWING RESULTS IN THE FUTURE. PER RISK ASSESSMENT, IF THE PATIENT RECEIVED A FALSE POSITIVE RESULT FOR CT OR GC, THE CDC RECOMMENDS TREATMENT FOR THE PATIENT IS ANTIBIOTICS. THE POTENTIAL IMPACT TO THE PATIENT WOULD BE THEREFORE BE INCONVENIENCE, ANXIETY, AND UNNECESSARY ANTIBIOTIC USE. THE RISK OF REPORTING AN INCORRECT STD DIAGNOSTIC RESULT IS CONSIDERED SERIOUS. THE SAMPLES WERE RE-TESTED BY THE CUSTOMER TWO DAYS AFTER REPORTING THE INITIAL RESULTS AND 29 CORRECTED RESULTS WERE REPORTED TO THE CLINICIANS. HOLOGIC WILL WORK WITH CUSTOMER TO PROVIDE TRAINING TO THE OPERATORS ON PROPER SAMPLE SHIELD REPLACEMENT.