ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT

Additional Manufacturer Narrative

COMPLAINT INVESTIGATION WILL BE PERFORMED. NOTE: LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT (LIST 4J86-90) IS SIMILAR TO THE ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT (LIST 1N30-90) SOLD IN THE UNITED STATES. TICKET DOES NOT REFERENCE A US LIST 1N30-90 LOT NUMBER.

Description of Event or Problem

THE ABBOTT REALTIME HCV ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HEPATITIS C VIRAL RIBONUCLEIC ACID (HCV RNA) IN HUMAN SERUM AND PLASMA FROM HCV-INFECTED INDIVIDUALS. THE ABBOTT REALTIME HCV ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTIVIRAL THERAPY. THE ABBOTT REALTIME HCV ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV, OR TO BE USED AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION. CUSTOMER CALLED TO REPORT A FALSE DETECTED RESULT ON THE REALTIME HCV ASSAY. CUSTOMER IS USING OUR ASSAY FOR TISSUE DONOR SCREENING, WHICH IS OUTSIDE THE INTENDED USE OF THE ASSAY PER THE PACKAGE INSERT. CLARIFICATION RECEIVED FOR CLAIM OF SECOND SAMPLE IN FEBRUARY WITH SIMILAR ISSUE TO MDR 3005248192-2018-00004. THIS CASE FROM FEBRUARY WAS A SIMILAR CASE OF RUNNING THE REALTIME HCV ASSAY FOR SCREENING OF TISSUE DONORS. IT IS UNKNOWN IF THE RESULT WAS COMPARED TO RESULTS RECEIVED FROM OTHER LABORATORIES. CUSTOMER DID NOT REPEAT THAT SAMPLE AND TISSUE WAS DISCARDED BASED ON THE DETECTED REALTIME HCV ASSAY RESULT. THE DISCARDING OF POTENTIAL DONOR TISSUE DUE TO A FALSE DETECTED RESULT ON THE REALTIME HCV ASSAY IS REGARDED AS A SERIOUS INJURY DUE TO POTENTIAL IMPACT ON UNAVAILABILITY OF TISSUE FOR TRANSPLANT, ALTHOUGH THE CUSTOMER USED THE ASSAY FOR TISSUE DONOR SCREENING, WHICH IS OUTSIDE THE INTENDED USE OF THE ASSAY PER THE PACKAGE INSERT. THERE HAVE BEEN NO REPORTS OF IMPACT OR HARM TO PATIENT DUE TO THIS ISSUE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN BELGIUM USING REALTIME HCV LIST NUMBER 4J86-90 WHICH IS SAME/SIMILAR TO US FDA APPROVED REALTIME HCV LIST NUMBER 1N30-90.

Additional Manufacturer Narrative

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 CUSTOMER DATA REVIEW: DATA REVIEW OF RETURNED RESULTS LOGS FOR VALID RUNS INDICATES THAT ASSAY REAGENTS ARE PERFORMING AS INTENDED PER ASSAY SOFTWARE SPECIFICATIONS AS MEASURED BY THE INTERNAL CONTROL (IC) PERFORMANCE AND ACCEPTABLE CONTROL CONCENTRATIONS (LOW AND HIGH POSITIVE CONTROLS) AND THE NEGATIVE CONTROL. SUPPORTING INFORMATION REVIEW: THE ABBOTT REALTIME HCV PACKAGE INSERT (51-602124/R9) WAS REVIEWED. THIS LABELING REVIEW CONCLUDED THAT THE RELATED LABELING IS SUFFICIENT TO ADDRESS THE REPORTED COMPLAINT. PER THE ABBOTT REALTIME HCV PACKAGE INSERT 51-602124/R9: ·"OPTIMAL PERFORMANCE OF THIS TEST REQUIRES APPROPRIATE SPECIMEN COLLECTION, HANDLING, PREPARATION, AND STORAGE.". ·"AS WITH ANY DIAGNOSTIC TEST, RESULTS FROM THE ABBOTT REALTIME HCV ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS.". ·"A SPECIMEN WITH THE RESULT OF "NOT DETECTED" CANNOT BE PRESUMED TO BE NEGATIVE FOR HCV RNA.". NOTE: THE ABBOTT REALTIME HCV ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HEPATITIS C VIRAL RIBONUCLEIC ACID (HCV RNA) IN HUMAN SERUM AND PLASMA FROM HCV-INFECTED INDIVIDUALS. THE ABBOTT REALTIME HCV ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTIVIRAL THERAPY. THE ABBOTT REALTIME HCV ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV, OR TO BE USED AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION. QUALITY DATA REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW OF ABBOTT REALTIME HCV AMP RGT KIT (LIST 04J86-90) LOT 480302 (INCLUDING THE INDIVIDUAL COMPONENTS) DID NOT IDENTIFY ANY ISSUES RELATED TO REAGENT PERFORMANCE DURING THE PRODUCTION OR QUALITY CONTROL (QC) TESTING OF LOT 480302. THE CORRECTIVE AND PREVENTIVE ACTION (CAPA) REVIEW OF ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT (LIST 04J86-90) LOT 480302 (INCLUDING THE INDIVIDUAL COMPONENTS) DID NOT IDENTIFY ANY RECORDS RELATED TO THE ALLEGED COMPLAINT. RETAIN / FILE SAMPLE EVALUATION: PRODUCT EVALUATION FILE SAMPLE TESTING WAS NOT PERFORMED, SINCE THE REVIEW OF RESULTS LOG FILES (FOR VALID RUNS) FROM THE COMPLAINANT SITE SHOWS THERE IS NO INDICATION THAT THE ABBOTT REALTIME HCV ASSAY IS PERFORMING CONTRARY TO INTENDED USE, LABEL CLAIM, OR SPECIFICATION. RETURN MATERIAL WAS NOT AVAILABLE. COMPLAINT HISTORY REVIEW: THE LOT SPECIFIC COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINT TICKETS RELATED TO DISCREPANT RESULT ISSUES WHEN USING ABBOTT REALTIME HCV AMP RGT KIT (LIST 04J86-90) LOT 480302. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT (LIST 04J86-90) LOT 480302 WAS NOT IDENTIFIED.