ELECSYS C-PEPTIDE
Received Sep 5, 2025 · Event occurred Aug 11, 2025
Report 1823260-2025-02772 · MDR key 22983126
Device
Generic name
C-peptide Ivd, Kit, Chemiluminescent Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07027168188
Lot number
77777801
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Readings
- Low Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- High Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS C-PEPTIDE ASSAY ON A COBAS E 801 MODULE. SAMPLE 1: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 1096 NMOL/L. SAMPLE 2: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 468 NMOL/L. SAMPLE 3: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 1619 NMOL/L. SAMPLE 4: INITIAL RESULT: <6.67 NMOL/L. REPEAT RESULT: 876 NMOL/L.
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE ALARM TRACE SHOWED A REAGENT KIT ALARM (REAGENT PROBE). NO ISSUE WAS OBSERVED WITH THE REAGENT NEEDLE. THE PRE-ANALYTIC DATA SHOWED THAT THE SERUM HAD NO CLOTS OR BLOOD STREAKS. THE CUSTOMER REPLACED THE REAGENT WITH ANOTHER REAGENT PACK OF THE SAME LOT. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED, BECAUSE ANOTHER REAGENT KIT OF THE SAME LOT PERFORMED ACCORDING TO EXPECTATIONS AT THIS CUSTOMER¿S SITE. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED, ALTHOUGH THE ISSUE IS CONSISTENT WITH A TRANSPORTATION/STORAGE ISSUE. THE ISSUE WAS RESOLVED BY USING ANOTHER REAGENT PACK OF THE SAME LOT.