MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant triglycerides results for one patient sample tested on two cobas c 503 analytical unit analyzers.The sample initially resulted in a triglycerides value of 871 mg/dl when tested on the first c 503 analyzer.The sample was diluted 1:10 and repeated on the first c 503 analyzer, resulting in a value of 2593 mg/dl.The sample was repeated on the second c 503 analyzer, resulting in a triglycerides value of 845 mg/dl.The sample was diluted 1:10 and repeated on the second c 503 analyzer, resulting in a value of 2595 mg/dl.
Additional Manufacturer Narrative
The serial number of the first c503 system is (b)(6) and the serial number of the second c503 system is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were within specifications.A reagent or analyzer issue can be ruled out.A review of the reaction data showed an oxygen depletion during the assay reaction, leading to falsely low results.A visual inspection of the sample showed high lipemia.The investigation did not identify a product issue.The issue is consistent with lipemia in the sample interfering with the assay reaction.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES ASSAY
• 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: 22077666
• Report Number: 1823260-2025-01583
• Device Sequence Number: 13136859
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951595
• 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): 06/27/2025

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 Catalogue Number: 08058687190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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 Age: 32 YR
• Patient Sex: Male