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

Catalog Number	05171407190
Medical Device Problem Codes	High Test Results (2457); Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number is (b)(6).The field service engineer investigated the event and determined that the reagent had an abnormal color, which indicates a reaction or contamination.He also found crystalline deposits near the reagent inlet.He performed a test using deionized water and probe cleaning solution, which confirmed that the crystalline material caused lipid-related contamination.He performed comprehensive cleaning and maintenance.The customer has not reported any other issues after the service.The investigation is ongoing.
Event or Problem Description
The initial reporter alleged abnormally elevated triglycerides assay results from approximately 100 patient samples tested on the cobas 8000 c702 module.One example of the alleged abnormally elevated assay result was provided: on (b)(6) 2026: the customer had an air conditioning malfunction.The analyzer was located near an open window.The patient's initial result was 7.32 mmol/l.On (b)(6) 2026: the qcs were out of range (high).The customer replaced the reagent pack and reran the qcs and patient samples; the repeat qcs were within the specified ranges.The repeat result was 1.41 mmol/l.This result was deemed normal.
Additional Manufacturer Narrative
The investigation reviewed the data provided by the customer: the qc results from the old reagent pack were elevated.The qc results from the new reagent pack were within the specified ranges.The reaction curves revealed significantly increased baseline absorbances.The environmental factors included high temperature and humidity (>30°c and >60%), exacerbated by a malfunctioning air-conditioning unit in the laboratory.The investigation determined that environmental conditions (reagent contamination by external crystalline deposits under elevated temperature and humidity) caused the event.The investigation did not identify a product problem.

• 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: 25055797
• Report Number: 1823260-2026-01709
• Device Sequence Number: 9427264
• 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): 06/01/2026

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: 09/30/2026
• Device Catalogue Number: 05171407190
• Device Lot Number: 90988301
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/01/2026
• 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