AC2

Description of Event or Problem

(B)(6) REPORTED THAT THEY HAD ONE AC2 ASSAY RUN WITH MORE POSITIVES THAN NORMAL (GC POSITIVE RATE WAS 1%). THE RUN (CONSISTING OF BOTH SWAB AND URINE SAMPLES) DONE ON THE PANTHER ON (B)(6) 2017 WAS A VALID RUN AND THE LABORATORY SAID THAT THEY DIDN'T IDENTIFY A PATTERN TO THE RUN. THE LABORATORY RELEASED THE RESULTS. A PHYSICIAN QUESTIONED FOUR OF THE RESULTS FOR SWAB AND URINE SAMPLES AND SENT FOR NEW PATIENT COLLECTIONS FOR THESE FOUR QUESTIONABLE RESULTS. ALL FOUR NEWLY COLLECTED SAMPLES WERE TESTED AS NEGATIVE. WHEN LABORATORY HEARD FROM THE PHYSICIAN, THEY CONTACTED HOLOGIC. HOLOGIC REVIEWED THE INSTRUMENT LOGS FOR THE RUN WITH THE HIGHER POSITIVITY RATE WHICH SHOWED NO INSTRUMENT OR REAGENT PREPARATION RELATED ISSUE. THERE WAS NO SIGN OF GROSS CONTAMINATION. HOLOGIC REQUESTED THE SAMPLES BACK (BOTH THE INITIAL SAMPLE WHICH TESTED POSITIVE AND THE SAMPLE TAKEN FROM THE RE-TEST) AND THEY WERE NOT AVAILABLE. HOLOGIC COULD NOT CONFIRM THE INITIAL OR SECONDARY SAMPLE TEST RESULTS. AN INCORRECT RESULT COULD BE DUE TO A KIT OR SAMPLE MISHANDLING ISSUE OR THE SAMPLES COULD BE LOW TITER SAMPLES. HOLOGIC RECOMMENDED CUSTOMER TO DISCARD ALL OPEN KITS AND CLEAN THE LAB. HOLOGIC INVESTIGATED THE AC2 KIT ASSOCIATED WITH THE REPORT OF A HIGHER POSITIVITY RATE, AND DID NOT DETERMINE ANY ISSUES ASSOCIATED WITH THE RELEASE OF THE KIT. HOLOGIC DETERMINED IT WAS LIKELY TO BE SAMPLE RELATED ISSUE DUE TO CONTAMINATION.

Additional Manufacturer Narrative

HOLOGIC INVESTIGATED THE AC2 KIT (ML 197107) ASSOCIATED WITH THE REPORT OF A HIGHER THAN NORMAL GC POSITIVITY RATE (THE CUSTOMER INDICATED THAT THEIR TYPICAL POSITIVITY RATE IS ~ 1%). THE AC2 LOT MET QUALITY CONTROL (QC) RELEASE SPECIFICATIONS, AND PERFORMED AS EXPECTED. DURING QC RELEASE TESTING, SPECIFICITY (ABILITY TO CORRECTLY IDENTIFY NEGATIVE SAMPLES) OF ML 197107, WAS TESTED. THE LOT MET SPECIFICITY REQUIREMENTS (ALL VALID REPLICATES TESTED WERE NEGATIVE). INVESTIGATIONAL TESTING WAS PERFORMED USING A RETENTION KIT OF THE LOT CONFIRMING 100% SPECIFICITY. THERE IS NO EVIDENCE THAT THE AC2 LOT IN QUESTION, ML 197107, HAS A SYSTEMIC CONTAMINATION ISSUE, AS THIS LOT HAS GONE TO OVER 200 CUSTOMERS AND THERE HAVE BEEN NO TREND OF CUSTOMER COMPLAINTS WITH A HIGH POSITIVITY RATE ATTRIBUTABLE TO THE LOT REAGENTS. HOLOGIC DETERMINED THAT THE INCREASE IN POSITIVITY RATE (AS STATED BY THE LAB) WAS LIKELY DUE TO CONTAMINATION OF THE KIT REAGENTS USED IN THE RUN ((B)(6) 2017). HOLOGIC RECOMMENDED THAT THE CUSTOMER DISCARD THE OPEN AC2 KIT THAT WAS USED IN THAT PARTICULAR RUN AND CLEAN THE LAB. THIS INFORMATION WAS COMMUNICATED TO THE LABORATORY ON 7/24/2017.

Description of Event or Problem

(B)(6) REPORTED THAT THEY HAD ONE AC2 ASSAY RUN WITH MORE POSITIVES THAN NORMAL (GC POSITIVE RATE WAS 1%). THE RUN (CONSISTING OF BOTH SWAB AND URINE SAMPLES) DONE ON THE PANTHER ON (B)(6) 2017 WAS A VALID RUN AND THE LABORATORY SAID THAT THEY DIDN'T IDENTIFY A PATTERN TO THE RUN. THE LABORATORY RELEASED THE RESULTS. A PHYSICIAN QUESTIONED FOUR OF THE RESULTS FOR SWAB AND URINE SAMPLES AND SENT FOR NEW PATIENT COLLECTIONS FOR THESE FOUR QUESTIONABLE RESULTS. ALL FOUR NEWLY COLLECTED SAMPLES WERE TESTED AS NEGATIVE. WHEN LABORATORY HEARD FROM THE PHYSICIAN, THEY CONTACTED HOLOGIC. HOLOGIC REVIEWED THE INSTRUMENT LOGS FOR THE RUN WITH THE HIGHER POSITIVITY RATE WHICH SHOWED NO INSTRUMENT OR REAGENT PREPARATION RELATED ISSUE. THERE WAS NO SIGN OF GROSS CONTAMINATION. HOLOGIC REQUESTED THE SAMPLES BACK (BOTH THE INITIAL SAMPLE WHICH TESTED POSITIVE AND THE SAMPLE TAKEN FROM THE RE-TEST) AND THEY WERE NOT AVAILABLE. HOLOGIC COULD NOT CONFIRM THE INITIAL OR SECONDARY SAMPLE TEST RESULTS. AN INCORRECT RESULT COULD BE DUE TO A KIT OR SAMPLE MISHANDLING ISSUE OR THE SAMPLES COULD BE LOW TITER SAMPLES.