ELECSYS C-PEPTIDE

Additional Manufacturer Narrative

THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THERE WAS NO CALIBRATION INFLUENCE OBSERVED. THE QC WAS WITHIN RANGE PRIOR TO THE SAMPLE MEASUREMENT. THERE WAS NO DATA ALARM FOR SUCTION ABNORMALITY AT THE TIME OF THE INITIAL TEST MEASUREMENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS C-PEPTIDE ASSAY ON A COBAS E 801 MODULE. INITIAL RESULT: 0.7 NG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, PROMPTING THE REPEAT OF THE SAMPLE. REPEAT RESULT: 23.2 NG/ML.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED ADDITIONAL DISCREPANT ELECSYS C-PEPTIDE RESULTS FROM A DIFFERENT URINE SAMPLE FROM THE SAME PATIENT: ON 19-JUN-2025, THE INITIAL RESULT WAS 0.4 NG/ML. ON 20-JUN-2025, THE REPEAT RESULT WAS 134 NG/ML. THE PHYSICIAN DETERMINED THAT THE REPEAT RESULT WAS CORRECT. THE PROVIDED RESULT DATA PRINTOUT SHOWED NUMEROUS DATA ALARMS, WHICH INDICATE THAT AN EXPIRED REAGENT WAS USED FOR THE ASSAY. THE FIELD SERVICE ENGINEER INVESTIGATED THE EVENT AND DETERMINED THAT IT WAS CAUSED BY THE CUSTOMER'S USE OF AN EXPIRED ASSAY DILUIENT. THE DILUENT WAS REPLACED AND SUCCESSFUL REPEATABILITY TESTS WERE PERFORMED. PRODUCT LABELING STATES: "DILLUENT MULTIASSAY STORAGE AND STABILITY STORE AT 2-8 °C. STABILITY: UNOPENED AT 2-8 °C UP TO THE STATED EXPIRATION DATE. ON THE COBAS E 402 AND COBAS E 801 ANALYZER - 16 WEEKS." THE CAUSE OF THE EVENT WAS DUE TO AN OFF-LABEL USE (THE CUSTOMER USED AN EXPIRED ASSAY DILUENT). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.