MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TRIGLYCERIDES; TRIGLYCERIDES ASSAY

Catalog Number	08058687190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable triglycerides results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 295 mg/dl.The sample was tested on another module and the result was 85.5 mg/dl.The sample was repeated on the same module as the initial result and the repeated result was 87 mg/dl.The sample was repeated as the initial result did not match the patient's clinical history.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration and qc were acceptable.The alarm trace showed several "abnormal aspiration" alarms on the date of the event, which are indicative of a possible pre-analytical issue.The field service representative performed checks and did not find any abnormalities.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue was excluded.The investigation did not identify a product problem.The investigation determined the issue was consistent with a pre-analytical handling issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21333984
• Report Number: 1823260-2025-00358
• Device Sequence Number: 8624174
• Product Code: CDT
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/19/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 08058687190
• Device Lot Number: 83647901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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