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

Catalog Number	05171407190
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable triglycerides/gb (glycerol blanked) results from the cobas 8000 c702 module.The initial result was 0.01 mmol/l.The repeat result using a reduced sample volume was 0.02 mmol/l.On (b)(6) 2025, the repeat result was 0.76 mmol/l.Using another sample from the patient, the result was 2.34 mmol/l.It was unclear if this sample was from the same venipuncture.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.Since the testing of a separate sample from the patient generated reliable results, the event was consistent with a sample-specific / pre-analytical issue.Correct pre-analytic sample handling is within the customer's responsibility.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: 23097854
• Report Number: 1823260-2025-03211
• Device Sequence Number: 8618061
• 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): 10/30/2025

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 Catalogue Number: 05171407190
• Device Lot Number: 861356
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN CALCIUM TABLETS; BCG-PPD; EZETIMIBE TABLETS; MECOBALAMIN; METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS; NIFEDIPINE; TORASEMIDE
• Patient Age: 36 YR
• Patient Sex: Female