MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with triglycerides (trigl) assay on a cobas c503 analytical unit.Initial result: 721 mg/dl.The customer noticed that the initial result was high.No questionable result was reported outside the laboratory and the sample was repeated.Repeat result: 199 mg/dl.The repeat result was deemed to be correct and reported outside the laboratory.
Additional Manufacturer Narrative
The cobas c503 analytical unit serial number was (b)(6).The calibration and qc data were provided and they were acceptable.The alarm trace was provided from (b)(6) 2025 to (b)(6) 2025 and it did not show any abnormality.The investigation is ongoing.
Additional Manufacturer Narrative
Sections a2, a3a and b7 were updated.The investigation is ongoing.
Additional Manufacturer Narrative
The instrument's maintenance was performed within specifications.A general reagent problem can be excluded because calibration and qc were acceptable.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21774186
• Report Number: 1823260-2025-01019
• Device Sequence Number: 9647696
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 06/24/2025

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: 01/31/2026
• Device Catalogue Number: 08058687190
• Device Lot Number: 85162701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 06/03/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/24/2025
• 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: 51 YR
• Patient Sex: Female