MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable triglycerides (trigl) assay results from multiple patient samples tested on the cobas c 503 analytical unit.The following are examples of discrepant results: patient sample 1 on (b)(6) 2025: the initial result was 2.7 mmol/l.The repeat result was 4.15 mmol/l.Patient sample 2 on (b)(6) 2025: the initial result was 2.53 mmol/l.The repeat result was 1.53 mmol/l.Patient sample 3 on (b)(6) 2025: the initial result was 3.07 mmol/l with a data flag.The repeat result was 2.03 mmol/l with a data flag.Patient sample 4 on (b)(6) 2025: the initial result was 2.07 mmol/l with a data flag.The repeat result was 1.09 mmol/l with a data flag.
Additional Manufacturer Narrative
The patient samples were received for investigation.The investigation performed a reproducibility test, which showed no discrepant or out-of-range results.The investigation determined that the event was consistent with factors related to the customer's site; an analyzer or a reagent issue was excluded.The investigation reviewed the analyzer's cell blank summary, which showed several out-of-range results.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The issue was related to factors on the customer's site and was not accessible, as double determinations for triglycerides were not specified.The cause of the event could not be determined.

• 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: 21993390
• Report Number: 1823260-2025-01434
• Device Sequence Number: 4478552
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/23/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 12/16/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 08/27/2025; 12/23/2025
• 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