THE ACCOUNT STATED THE INITIAL AND REPEAT HIV-1/2 EIA REACTIVE RATES ARE OUTSIDE THE RANGES STATED IN THE HIV-1/2 EIA PACKAGE INSERT. FOR EXAMPLE, 37 BLOOD DONORS TESTED HIV-1/2 EIA INITIAL AND REPEAT REACTIVE BUT WESTERN BLOT TESTING SHOWED 26 NEGATIVE, 8 INDETERMINATE AND 3 POSITIVE. THE ACCOUNT PROCESSES USING MULTIPLE COMMANDER FPCS AND PPCS. SERVICE WAS REQUESTED FOR THE COMMANDER PPCS AND ALL WERE PERFORMING WITHIN SPECIFICATION. THE REACTIVE HIV-1/2 EIA RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. NO IMPACT TO PT MANAGEMENT WAS REPORTED.
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Patient 1
(INVESTIGATION IS IN PROCESS). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
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Patient 1
(B)(4): THE INVESTIGATIONAL TESTING ALONG WITH THE QUALITY DATA REVIEW DETERMINED THAT A PRODUCT DEFICIENCY IS NOT LIKELY. ACCEPTANCE CRITERIA WERE MET FOR THE COMPLAINT TRACKING AND TRENDING REVIEW. ABBOTT CLINICAL SPECIFICITY TESTING OF MATERIAL DEMONSTRATED THAT THE PRODUCT CONTINUES TO MEET EXPECTED CLINICAL SPECIFICITY REQUIREMENTS. THE ISSUE OF SPECIMENS THAT ARE INITIALLY AND REPEATEDLY REACTIVE AND NEGATIVE OR INDETERMINATE ON SUPPLEMENTAL TESTING IS ADDRESSED IN THE ABBOTT HIVAB HIV-1/HIV-2 (RDNA) EIA PACKAGE INSERT. THE INVESTIGATION TEAM DETERMINED THAT THE ABBOTT HIVAB HIV-1/HIV-2 (RDNA) EIA ASSAY IS PERFORMING AS INTENDED AND MEETING ITS SAFETY, EFFECTIVENESS AND LABEL CLAIMS. TO EVALUATE THE PERFORMANCE OF LOTS 62241M101, 62334M201, AND 64956M100, AND TO ENSURE THAT THE PRODUCT CONTINUES TO MEET PERFORMANCE EXPECTATIONS, THE INVESTIGATION TEAM TESTED 450 SERUM PATIENT SPECIMENS WITH KITS FROM OUR INVENTORY OF LOTS 62241M100, 62334M200, AND 64956M100. THESE FILE KITS ARE MASTERLOTS OF THE REAGENT LOTS IN QUESTION AND ARE MADE OF THE SAME MATERIAL. FILE KITS 62241M100 AND 64956M100 PRODUCED 1 INITIALLY REACTIVE SAMPLE EACH, BUT DID NOT REPEAT. FILE KIT 62334M200 DID NOT PRODUCE ANY INITIAL REACTIVE RESULTS. UNFORTUNATELY, THE INVESTIGATION TEAM WAS UNABLE TO PERFORM TESTING USING REAGENT LOT 63454M101 BECAUSE IT HAD EXPIRED PRIOR TO PERFORMING OUR TESTING. THE INVESTIGATION TEAM ANALYZED ABBOTT TESTING DATA AND IT INDICATES THAT THE PRODUCT CONTINUES TO MEET THE EXPECTED CLINICAL SPECIFICITY LISTED IN THE PACKAGE INSERT. COMPLAINT RECORDS FOR THE ASSAY WERE REVIEWED TO DETERMINE IF OTHER CUSTOMERS HAD EXPERIENCED SIMILAR ISSUES THAT MIGHT WARRANT FURTHER INVESTIGATION. THIS REVIEW DID NOT SHOW ANY UNUSUAL ACTIVITY RELATED TO THE ACCOUNT'S OBSERVATION. IN SUMMARY, THE COMPLAINT DATA REVIEW INDICATE THAT THESE LOTS ARE PERFORMING ACCEPTABLY. THE ISSUE OF SPECIMENS THAT ARE INITIALLY AND REPEATEDLY REACTIVE AND NEGATIVE OR INDETERMINATE ON SUPPLEMENTAL TESTING IS ADDRESSED IN THE ABBOTT HIVAB HIV-1/HIV-2 (RDNA) EIA PACKAGE INSERT. THE INTERPRETATION OF RESULTS SECTION OF THE PACKAGE INSERT STATES: SPECIMENS FOUND TO BE REPEATEDLY REACTIVE BY ABBOTT HIVAB HIV-1/HIV-2 (RDNA) EIA MUST BE INVESTIGATED BY ADDITIONAL, MORE SPECIFIC SUPPLEMENTAL TESTS. ADDITIONALLY, IT STATES: THE INTERPRETATION OF RESULTS OF SPECIMENS FOUND TO BE REPEATEDLY REACTIVE BY ABBOTT HIVAB HIV-1/HIV-2 (RDNA) EIA AND NEGATIVE OR INDETERMINATE ON ADDITIONAL MORE SPECIFIC SUPPLEMENTAL TESTING IS UNCLEAR; FURTHER CLARIFICATION MAY BE OBTAINED BY TESTING ANOTHER SPECIMEN TAKEN THREE TO SIX MONTHS LATER. THIS IS A FINAL REPORT.