ELECSYS C-PEPTIDE
Received Aug 25, 2025 · Event occurred Jul 29, 2025
Report 1823260-2025-02604 · MDR key 22883104
Device
Generic name
C-peptide Ivd, Kit, Chemiluminescent Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07027168190
Lot number
80858100
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS C-PEPTIDE RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 2.26 NMOL/L. THE REPEAT RESULT WAS 0.01 NMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.