ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT

Description of Event or Problem

THE ABBOTT REALTIME CT/NG ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR THE DIRECT, QUALITATIVE DETECTION OF THE PLASMID DNA OF (B)(6). THE ASSAY MAY BE USED TO TEST THE FOLLOWING SPECIMENS FROM SYMPTOMATIC INDIVIDUALS: FEMALE ENDOCERVICAL SWAB, CLINICIAN-COLLECTED VAGINAL SWAB, AND PATIENT-COLLECTED VAGINAL SWAB SPECIMENS; MALE URETHRAL SWAB SPECIMENS; AND FEMALE AND MALE URINE SPECIMENS. THE ASSAY MAY BE USED TO TEST THE FOLLOWING SPECIMENS FROM ASYMPTOMATIC INDIVIDUALS: CLINICIAN-COLLECTED VAGINAL SWAB AND PATIENT-COLLECTED VAGINAL SWAB SPECIMENS; FEMALE AND MALE URINE SPECIMENS. A CUSTOMER IN (B)(6) REPORTED THAT A SAMPLE GENERATED A (B)(6) RESULT WHEN RUN ON THE CE MARKED ABBOTT REALTIME CT/NG ASSAY (LIST 02G28-91) AND A (B)(6) RESULT WHEN THE SAME SAMPLE WAS RETESTED USING THE CE MARKED ABBOTT REALTIME CT/NG ASSAY. FOLLOW-UP WITH THE CUSTOMER INDICATES THEY REPORTED THE PATIENT RESULT AS (B)(6). THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. IT IS UNKNOWN AT THIS TIME IF A MALFUNCTION HAS OCCURRED. IF THIS OBSERVATION WAS CAUSED BY AN ABBOTT PRODUCT MALFUNCTION AND THAT MALFUNCTION WERE TO RECUR, A (B)(6) RESULT IN THE CT/NG ASSAY WOULD NOT IDENTIFY A PATIENT AS INFECTED WITH (B)(6) AND MAY RESULT IN WITHHOLDING NECESSARY THERAPY OR SPREAD OF THE DISEASE. THIS MAY LEAD TO SERIOUS INJURY TO THE PATIENT IF THE MALFUNCTION WERE TO RECUR. THIS MDR IS SUBMITTED BECAUSE THERE IS AN ABBOTT REALTIME CT/NG ASSAY COMMERCIALLY AVAILABLE IN THE U.S. (LIST 8L07-91) THAT IS SIMILAR TO THE CE MARKED ABBOTT REALTIME CT/NG ASSAY (LIST 02G28-91), AND MAY HAVE THE SAME POTENTIAL FOR SERIOUS INJURY TO THE PATIENT IF THE MALFUNCTION WERE TO RECUR. ELEVATED COMPLAINT INVESTIGATION (B)(4) IS IN PROGRESS.

Additional Manufacturer Narrative

FOLLOWING IS A SUMMARY OF ELEVATED COMPLAINT INVESTIGATION (ECINV) (B)(4)FOR MDR 3005248192-2015-00002 FOLLOW-UP REPORT 1: COMPLAINT BACKGROUND THE CUSTOMER FROM THE LAB (B)(6) REPORTED DISCREPANT PATIENT RESULTS WHILE USING ABBOTT REALTIME CT/NG AMPLIFICATION KIT LIST 02G28-91 LOT NUMBER 456703. THERE WERE SIX SAMPLES THAT WERE REPORTED AS A DISCREPANT RESULT FOR N. GONORRHOEAE (NG). THESE SAMPLES ARE CONSIDERED FALSE POSITIVES FOR NG. FIVE OF THE SAMPLES WERE TESTED TWICE ((B)(4)). THESE SAMPLES WERE POSITIVE ON THE FIRST TEST AND NEGATIVE ON THE SECOND TEST. ONE WAS TESTED THREE TIMES ((B)(4)); POSITIVE ON THE FIRST TEST AND NEGATIVE ON THE SECOND AND THIRD TEST IT IS NOT KNOWN WHY THIS SAMPLE WAS CHOSEN TO BE TESTED A THIRD TIME. ADDITIONALLY, THERE WAS ONE PATIENT WHICH HAD DISCREPANT RESULTS FOR CT AND NG. THIS PATIENT HAD A URINE SAMPLE AND A SWAB SAMPLE. ON FIRST TEST, THE URINE WAS CT POSITIVE AND NG NEGATIVE WHILE THE SWAB WAS CT NEGATIVE AND NG POSITIVE. UPON RETEST, BOTH URINE AND SWAB WERE CT NEGATIVE AND NG POSITIVE. THIS SAMPLE IS CONSIDERED A FALSE POSITIVE FOR CT AND A FALSE NEGATIVE FOR NG. INVESTIGATION INTO THIS COMPLAINT INCLUDED AN EXISTING DATA REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: EXISTING DATA REVIEW: SUPPORTING INFORMATION REVIEW: THE ABBOTT REALTIME CT/NG PACKAGE INSERT ((B)(4)) WAS REVIEWED. THE USER IS RESPONSIBLE FOR VALIDATING THE COLLECTION, TRANSPORTATION, AND STORAGE OF SPECIMENS NOT COLLECTED, TRANSPORTED, AND STORED PER THIS PACKAGE INSERT. PERFORMANCE CLAIMS HAVE NOT BEEN ESTABLISHED FOR SPECIMEN COLLECTION, TRANSPORTATION, AND STORAGE THAT DIFFERS FROM THE INSTRUCTIONS PROVIDED IN THIS PACKAGE INSERT FOR THE USE OF THE ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT. ((B)(4)) - SPECIMEN COLLECTION SECTION, PAGE 20. OPTIMAL PERFORMANCE OF THIS TEST REQUIRES APPROPRIATE SPECIMEN COLLECTION, HANDLING, AND STORAGE. ((B)(4)) - LIMITATIONS OF THE PROCEDURE SECTION, PAGE 43. A NEGATIVE RESULT DOES NOT EXCLUDE THE POSSIBILITY OF INFECTION BECAUSE RESULTS ARE DEPENDENT ON APPROPRIATE SPECIMEN COLLECTION AND ABSENCE OF INHIBITORS. THE PRESENCE OF PCR INHIBITORS MAY CAUSE INVALID RESULTS WITH THIS PRODUCT. ((B)(4))- LIMITATIONS OF THE PROCEDURE SECTION, PAGE 43. AS WITH ANY DIAGNOSTIC TEST, RESULTS FROM THE ABBOTT REALTIME CT/NG ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS. ((B)(4))- LIMITATIONS OF THE PROCEDURE SECTION, PAGE 44. A POSITIVE RESULT FOR THE PRESENCE OF N. GONORRHOEAE NUCLEIC ACIDS IN THE ENDOCERVICAL SPECIMENS DOES NOT ESTABLISH THE CAUSATIVE AGENT FOR SALPINGITIS OR PID. A NEGATIVE RESULT FOR THE N. GONORRHOEAE NUCLEIC ACIDS IN THE ENDOCERVICAL SPECIMEN DOES NOT EXCLUDE GONOCOCCAL INFECTION AS A CAUSE OF ASCENDING INFECTION. ((B)(4))- LIMITATIONS OF THE PROCEDURE SECTION, PAGE 43. THE LOWER LIMIT OF DETECTION (LOD) OF THE ASSAY IS 320 COPIES OF PLASMID DNA PER 400 [?]L. THE CT/NG ASSAY TARGETS THE CHLAMYDIA CRYPTIC PLASMID (PRESENT AT APPROXIMATELY 10 COPIES PER CHLAMYDIA ORGANISM) AND THE MULTICOPY OPACITY GENE OF NEISSERIA GONORRHOEAE (REPEATED APPROXIMATELY 11 TIMES PER ORGANISM). THUS 320 COPIES OF SYNTHETIC TARGET PER SAMPLE INPUT (400 [?]L) TRANSLATES TO APPROXIMATELY 30-40 ORGANISMS. ((B)(4))- SPECIFIC PERFORMANCE CHARACTERISTICS SECTION, PAGE 45. THE M2000SP OPERATIONS MANUAL (LIST 9K20-06; 200681-106[?]OCTOBER 2012) WAS REVIEWED: AS PART OF DAILY MAINTENANCE, THE LIQUID SYSTEM SHOULD BE CHECKED FOR LEAKS (PAGE 9-4). LEAKS COULD CAUSE PIPETTING INACCURACY AND CROSS-CONTAMINATION AND IT IS NOT RECOMMEND TO OPERATE THE M2000SP IF ANY LEAKS ARE VISIBLE (PAGE 9-16). CUSTOMER DATA REVIEW: THE RUNS ON (B)(6) 2014 (RESULTS LOG 242), (B)(6) 2014 (RESULTS LOG 245), (B)(6) 2014 (RESULTS LOG 246), (B)(6) 2014 (RESULTS LOG 2560, AND (B)(6) 2014 (RESULTS LOG 258) WERE VALID, MET ALL ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CUTOFF CONTROLS OR NEGATIVE CONTROLS. THERE IS NO INDICATION THAT THE ABBOTT REALTIME CT/NG AMPLIFICATION KIT (LIST 02G28-91) LOT 456703 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS. QUALITY DATA REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ABBOTT REALTIME CT/NG AMPLIFICATION KIT (LIST 02G28-91) LOT 456703 AND ITS COMPONENTS WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE ALLEGED COMPLAINT DURING THE PRODUCTION OR THE RELEASE TESTING FOR LOT 4546703. THE CAPA REVIEW FOR ABBOTT REALTIME CT/NG AMPLIFICATION KIT (LIST 02G28-91) LOT 456703 WAS PERFORMED AND DID NOT IDENTIFY ANY INTERNAL OR POST-PRODUCTION USE ISSUES RELATED TO THIS COMPLAINT. COMPLAINT HISTORY REVIEW: THE LOT SPECIFIC COMPLAINT HISTORY REVIEW FOR ABBOTT REALTIME CT/NG AMPLIFICATION KIT (LIST 02G28-91) LOT 456703 DID NOT IDENTIFY ANY ADDITIONAL COMPLAINT TICKETS RELATED TO THIS COMPLAINT. PRODUCT DEFICIENCY DECISION BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS A PRODUCT DEFICIENCY FOR ABBOTT REALTIME CT/NG AMPLIFICATION KIT (LIST 02G28-91) LOT 456703 WAS NOT IDENTIFIED. THEREFORE, THIS COMPLAINT WILL BE DISPOSITIONED AS UNCONFIRMED.

Additional Manufacturer Narrative

ELEVATED COMPLAINT INVESTIGATION (B)(4) IS ONGOING AT ABBOTT MOLECULAR FOR MDR 3005248192-2015-00002. AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA AFTER THE COMPLAINT INVESTIGATION IS COMPLETED.