MAUDE Adverse Event Report: Roche Diagnostics Triglycerides; Triglyceride test system

Catalog Number	20767107322
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with triglycerides assay on a cobas 6000 c (501) module.The initial result was 594 mg/dl.The customer noticed that the initial result was high and did not match the patient's clinical picture or previous results, prompting a repeat of the sample.The repeat results were: 788 mg/dl (accompanied by an invalidating data flag).5651 mg/dl (accompanied by an invalidating data flag).4425 mg/dl.The repeat result of 4425 mg/dl was deemed to be correct.
Additional Manufacturer Narrative
The triglycerides reagent expiration date was not provided.The cobas 6000 c 501 module serial number was (b)(6).The visual inspection of the sample showed that it was lipemic.The investigation is ongoing.

• Brand Name: Triglycerides
• Common Device Name: Triglyceride test system
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50947532
• Report Number: 1823260-2026-04026
• Device Sequence Number: 9499660
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K873049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Catalogue Number: 20767107322
• Device Lot Number: 951776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• 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