ACCESS INHIBIN A REAGENT

Additional Manufacturer Narrative

THE FULL IDENTIFIER FOR THIS EVENT IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. THE ACCESS INHIBIN A REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER NOTED ISSUES WITH SYSTEM CHECK FAILING ON (B)(6) 2021 BUT WAS ABLE TO OBTAIN A SUCCESSFUL SYSTEM CHECK WITHOUT ANY INTERVENTIONS NOTED BY THE CUSTOMER. A PRECISION RUN PERFORMED BY THE CUSTOMER ON (B)(6) 2021 PASSED WITHIN SPECIFICATIONS; SYSTEM HARDWARE WAS VERIFIED. CUSTOMER PROVIDED DATA DEMONSTRATES A MALFUNCTION OF IMPRECISION FOR SEVERAL SAMPLES. THE IMPRECISION DEMONSTRATED EXCEEDS SPECIFICATIONS WHICH ARE FOUND IN THE ACCESS INHIBIN A INSTRUCTIONS FOR USE (IFU): PN A83946 G THIS ASSAY EXHIBITS TOTAL IMPRECISION = 8% AT CONCENTRATIONS GREATER THAN 30 PG/ML SEE ATTACHED DATA FOR REFERENCE. CUSTOMER TECHNICAL SPECIALIST DISCUSSED INSTRUMENT MAINTENANCE WITH CUSTOMER. CTS ALSO VERIFIED REAGENT STORAGE AND INHIBIN A SAMPLE STABILITY WITH CUSTOMER. IN CONCLUSION, A CAUSE FOR THE IMPRECISION MALFUNCTION CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

Description of Event or Problem

ON 29MARCH2021 THE CUSTOMER REPORTED THAT ON (B)(6) 2021, ERRONEOUS LOW INHIBIN A (ACCESS INHIBIN A, PART NUMBER A36097 AND LOT NUMBER 922981) RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, SERIAL NUMBER (B)(4)) FOR SEVERAL PATIENTS. CUSTOMER DID NOT INDICATE WHETHER THE ERRONEOUS INHIBIN A RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THE ERRONEOUS INHIBIN A RESULTS. SYSTEM PERFORMANCE INDICATORS SUCH AS CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED ISSUES WITH THE SYSTEM CHECK, PASSING SYSTEM CHECK WAS OBTAINED AFTER FAILING SYSTEM CHECK WITH NO INDICATION OF INTERVENTIONS PERFORMED BY CUSTOMER. SAMPLES WERE COLLECTED OFFSITE IN 12X75MM SERUM SEPARATOR TUBES; OTHER SAMPLE HANDLING INFORMATION SUCH AS SAMPLE CLOTTING TIME AND CENTRIFUGATION SPEED AND TIME WERE NOT PROVIDED. CUSTOMER NOTED THE SAMPLES WERE ALIQUOTED AND FROZEN FOR TRANSPORTATION AND THAWED AND TESTED UPON RECEIPT TO THE LABORATORY.