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

Catalog Number	07027168190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys c-peptide (c-peptide) result from one patient sample tested on the cobas e 801 analytical unit with serial number (b)(4).The initial result was reported outside of the laboratory.The c-peptide result allegedly did not fit or was not parallel to the measured elecsys insulin result.The initial c-peptide result was >40 ng/ml.The reporter did a recycling experiment with polyethylene glycol (peg) and the result was consistent with the original result.The insulin result was 18.2 uu/ml.This result was within the measurement range but higher than the reference interval.The patient sample was retested for insulin and the results were consistent the reagent lot number and the expiration date were requested but not provided.
Additional Manufacturer Narrative
The patient sample was received for investigation.The patient sample was not hemolyzed; the patient sample was noted to be lipemic.The results of c-peptide were proportional to the dilution ratio, which indicates that there was no hook effect.The investigation determined that there was no interference with heterophile antimouse antibodies (hama).The investigation excluded all interferences.
Additional Manufacturer Narrative
The investigation determined that there was no ruthenium (ru) interference in the sample.The investigation determined that the issue was consistent with the patient's chronic renal insufficiency.Product labeling states "elevated c-peptide levels may also result from renal insufficiency and obesity." the investigation did not identify a product problem.
Additional Manufacturer Narrative
Medwatch field b7: other relevant history was updated.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15959558
• Report Number: 1823260-2022-03963
• Device Sequence Number: 12144050
• Product Code: JKD
• UDI-Device Identifier: 04015630939992
• UDI-Public: 04015630939992
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2023

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 Catalogue Number: 07027168190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 01/09/2023; 02/08/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/03/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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