MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Codes	High Test Results (2457); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The alarm trace showed sample short alarms.The customer performed a precision check and found that triglycerides did not pass.The customer also performed a system wash.The field service engineer (fse) performed a hardware check, checked the cuvette wash liquid level, checked the rinse tube, performed a reagent carryover check.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable triglycerides results for 2 patient samples on a cobas c 503 analytical unit.The customer questioned the initial results as it did not match the patients' previous results which prompted them to repeat the samples.On (b)(6) 2025, sample 1 had an initial result of 388 mg/dl.The sample was repeated and the result was 155 mg/dl.The sample was repeated again on another c503 analyzer and the result was 157 mg/dl.On (b)(6) 2025, sample 2 had an initial result of 212 mg/dl.The sample was repeated twice and the result was 114 mg/dl and 115 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The calibration and qc recovery data provided were acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.Abnormal kinetics were observed for the initial sample run.The reaction curve is consistent with a pre-analytical issue.Additionally, there are sample short alarms that belong to the instrument, which may be traced back to non-ideal pre-analytical conditions.The service maintenance actions performed by the fse resolved the issue.The cause of the event could not be determined.

• Brand Name: TRIGLYCERIDES
• Common Device Name: TRIGLYCERIDES ASSAY
• 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: 23556767
• Report Number: 1823260-2025-04651
• Device Sequence Number: 9764381
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K951595
• 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): 12/18/2025

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: 08058687190
• Device Lot Number: 877983
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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
• Patient Sex: Unknown