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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 503 analyzer serial number is (b)(6).A review of the reaction data for the second sample showed an abnormal reaction for the initial value.The reaction data for the repeat result was normal.Calibration and controls were acceptable on the day of the event.Control recovery from 28-jun-2025 to 21-jan-2026 was not stable and was out of range most of the time.Precision studies were performed and were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with triglycerides on a cobas c 503 analytical unit.The first sample initially resulted in a triglycerides value of 232 mg/dl and it repeated as 112 mg/dl.The second sample initially resulted in a triglycerides value of 234 mg/dl on (b)(6) 2026 and it repeated as 92.1 mg/dl.
Additional Manufacturer Narrative
The field service engineer replaced and adjusted the sample probe.The cell rinse unit and levels were checked.Some patient samples were checked and had oily droplets.A rinse station was replaced.A review of the alarm trace showed abnormal aspiration alarms.The investigation determined the issue is consistent with insufficient pre-analytic sample handling, leading to a contaminated sample probe.

• 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: 24260453
• Report Number: 1823260-2026-00389
• Device Sequence Number: 8131527
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/02/2026

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: 06/30/2026
• Device Catalogue Number: 08058687190
• Device Lot Number: 88795401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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