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

Catalog Number	05171407190
Medical Device Problem Code	Prophylactic removal due to corrective action (4077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with triglycerides on a cobas 8000 c702 module.The customer stated the sample was lipemic.No questionable results were reported outside of the laboratory.The sample initially resulted in a triglycerides value of 2.22 mmol/l.The value did not match the patient's clinical diagnosis, so it was repeated.The sample was repeated using decreased sample volume after ultracentrifugation of the sample and it resulted in a value of 11.62 mmol/l accompanied by a flag indicating there were issues with the reaction kinetics.The sample was diluted 1:20 and repeated, resulting in a value of 39.03 mmol/l.A repeat value of 30.03 mmol/l after 1:20 dilution was also provided, but it is not known if this is an actual repeat value or if it was provided in error.The customer is questioning why the initial value of 2.22 mmol/l was not accompanied by a flag indicating an issue with reaction kinetics.
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The repeat value of 30.03 mmol/l was provided in error.The investigation determined the issue is related to the sample.A product problem could not be 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: 24731006
• Report Number: 1823260-2026-01164
• Device Sequence Number: 18747447
• 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): 04/22/2026

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: 909883
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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