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

Catalog Number	05171407190
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).It was noted that the sample was lipemic.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable triglyceride results for 1 patient sample on a cobas 8000 c702 module.The initial result was 1.25 mmol/l, and the repeated result was 1.31mmol/l.The sample was repeated with a dilution (1:10), and the result was 49.76 mmol/l.The sample was repeated because the results didn't match the patient's clinical diagnosis.
Additional Manufacturer Narrative
The qc was acceptable.Product labeling states: " extremely lipemic samples (triglycerides greater than 3000 mg/dl) can produce normal results." (3000 mg/dl is approximately 34 mmol/l) the alleged result exceeds the limit.The extremely high triglyceride concentration in the lipemic sample caused oxygen depletion during the reaction, resulting in the abnormal reaction curve and a false low result.The absorbance difference at mp5 and mp3 is below the specified limit(>1000).The abnormal peak in mp3, disturbing the steady absorbance increase, is the root cause for the result remaining unflagged.The missing flag is correct.The unusual peak in mp3, which is related to this particular sample/run, overrode the correct flag settings.The investigation did not identify a product problem.The investigation determined the issue was due to pre-analytical handling issues at the customer site.

• 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: 23730117
• Report Number: 1823260-2025-04968
• Device Sequence Number: 18577586
• 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): 01/15/2026

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: 03/31/2026
• Device Catalogue Number: 05171407190
• Device Lot Number: 86135601
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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