MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDE TEST SYSTEM

Catalog Number	20767107322
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).Sample material was requested for investigation.
Event or Problem Description
We received an allegation of questionable high results for multiple patient samples tested for triglycerides (trigl) on a cobas 6000 c501 module.A discrepant high result was provided for 1 patient sample.The initial result was 473.9 mg/dl.The repeat result was 311.1 mg/dl.
Additional Manufacturer Narrative
A sample quality issue was suspected.Ten samples with an oily film, along with sample probes, were submitted for investigation.The following findings were made: multiple inorganic substances were identified on the outer surface of the sample probes; within these, silicone was identified.The oily film was isolated on the sample aliquots.The analysis revealed that the oily film was from the separation gel in the sample containers.The investigation determined the event was due to a sample quality issue (oily film on the surface of the sample).A product problem was not identified.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDE TEST SYSTEM
• 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: 22586270
• Report Number: 1823260-2025-02249
• Device Sequence Number: 17278199
• Product Code: CDT
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/13/2026

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: 08/31/2025
• Device Catalogue Number: 20767107322
• Device Lot Number: 82371001
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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