MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

Catalog Number	05171407190
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable triglycerides assay result for a patient sample tested on a cobas 8000 cobas c 701 module.The initial result was 1.74 mmol/l.The repeat result after the sample was diluted 1:50 was 88.99 mmol/l.The repeat result after ultracentrifugation was 15.07 (accompanied by an invalidating data flag).
Additional Manufacturer Narrative
Per the method sheet: "extremely lipemic samples(triglycerides greater than 3000 mg/dl, about 34 mmol/l) can produce normal results." the result of 88.99 mmol/l exceeds this limit.The extremely high triglyceride concentration in the lipemic sample caused oxygen depletion during the reaction, resulting in the abnormal reaction curve and a falsely low result.The investigation determined that this is a sample-specific issue.There was no product problem identified.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
• 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: 24192165
• Report Number: 1823260-2026-00295
• Device Sequence Number: 8010011
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K873049
• 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): 04/10/2026

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: 05171407190
• Device Lot Number: 905127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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