MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE; C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

Catalog Number	07027168190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
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.
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.

• Brand Name: ELECSYS C-PEPTIDE
• Common Device Name: C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22883104
• Report Number: 1823260-2025-02604
• Device Sequence Number: 9640836
• Product Code: JKD
• UDI-Device Identifier: 04015630939992
• UDI-Public: 04015630939992
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 07027168190
• Device Lot Number: 80858100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown