FDA Adverse Event
Malfunction
Summary report: N
ELECSYS C-PEPTIDE
MDR report key: 22883104
·
Received August 25, 2025
Report
- Report Number
- 1823260-2025-02604
- Event Type
- Malfunction
- Date Received
- August 25, 2025
- Date of Event
- July 29, 2025
- Report Date
- September 18, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JKD
- UDI-DI
- 04015630939992
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2292104 | ELECSYS C-PEPTIDE | C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY | JKD | ROCHE DIAGNOSTICS | 80858100 | 04015630939992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |