ACCESS PSA

Additional Manufacturer Narrative

A1: THE FULL PATIENT IDENTIFIER IS CASE-(B)(4). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. D4, H4: NOT LOT NUMBER WAS PROVIDED. NO EXPIRATION DATE, NO UDI AVAILABLE AND NO DEVICE MANUFACTURED DATE WAS PROVIDED EITHER. THE ACCESS PSA REAGENT WAS NOT RETURNED FOR EVALUATION. ¿ NO HARDWARE OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. ¿ NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. ¿ THERE WERE NO EXAMPLES GIVEN OF THE SAME SPECIMEN FROM A PATIENT BEING TESTED ON MULTIPLE PLATFORMS. ALL EXAMPLES OF DISCREPANT RESULTS BETWEEN DIFFERENT PLATFORMS WERE ON DIFFERENT SAMPLES COLLECTED FROM THE PATIENTS IN QUESTION AND FROM A LARGE TIME FRAME OF SEVERAL MONTHS. ¿ THE ACCESS TOTAL PSA INSTRUCTIONS FOR USE (IFU) WARNS THAT ¿THE CONCENTRATION OF PSA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE PSA ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. IF, IN THE COURSE OF MONITORING A PATIENT, THE ASSAY METHOD USED FOR DETERMINING PSA LEVELS SERIALLY IS CHANGED, ADDITIONAL SEQUENTIAL TESTING SHOULD BE CARRIED OUT TO CONFIRM BASELINE VALUES.¿ ¿ THE ACCESS TOTAL PSA IFU WARNING WAS COMMUNICATED TO CUSTOMER. ¿ THE CUSTOMER'S CONCERNS WERE ESCALATED TO GLOBAL PRODUCT TECHNICAL SUPPORT (GPTS) FOR DISCUSSION. TESTOSTERONE AND PSA QUALITY CONTROL 10 PRECISION TESTS WERE PERFORMED AND PASSED WITHIN SPECIFICATIONS ON (B)(6) 2025. NO HARDWARE ISSUE IS SUSPECTED. IN CONCLUSION, THE PRIMARY CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS INSUFFICIENT EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OF SYSTEM OR SYSTEM COMPONENT HAS OCCURRED IN CONJUNCTION WITH THIS EVENT. NOTE: NINE (9) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS THE NINE PATIENTS WITH UNNECESSARY BIOPSY PERFORMED.

Description of Event or Problem

ON 16JAN2025 THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH PSA (ACCESS HYBRITECH PSA PROSTATE SPECIFIC ANTIGEN (PART NUMBER 37200, LOT NUMBER NOT PROVIDED) PATIENT RESULTS GENERATED ON CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER A30260 AND SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT PATIENT'S ARE CONSISTENTLY HAVING HIGHER PSA RESULTS THAN PREVIOUS TESTING PERFORMED WITH ALTERNATE METHODOLOGIES AND THE CUSTOMER REPORTED THAT NINE (9) PATIENT¿S HAD UNNECESSARY BIOPSIES DUE TO THE FALSE HIGH RESULTS, WHICH WERE MOSTLY BENIGN OR NEGATIVE FOR CANCER. NO FURTHER INFORMATION WAS PROVIDED. THIS MEDWATCH REPORT WILL ADDRESS THE FIRST PATIENT (PATIENT 1): THE QUESTIONED ACCESS PSA RESULT WAS 14.98 NG/ML ON 19NOV2024. THE PREVIOUS ABBOTT PSA RESULT WAS 8.11 NG/ML ON (B)(6) 2024. PROSTATE BIOPSY WAS PERFORMED ON (B)(6) 2024. THE REFERENCE RANGE USED BY THE CUSTOMER FOR ALL METHODS (BECKMAN, ROCHE AND ABBOTT) IS 0.00-4.00 NG/ML. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO ISSUES WITH QUALITY CONTROL (QC) MATERIAL HAVE BEEN REPORTED IN CONJUNCTION WITH THIS EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. NOTE: NINE (9) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS THE NINE PATIENTS WITH UNNECESSARY BIOPSY PERFORMED.