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

Catalog Number	05171407190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer stated that their qc was out of range, so they recalibrated the assay and reran qc successfully.The calibration recovery data showed the last two calibrations were accompanied by calibration error flags.The alarm trace did not contain a conspicuous event.It was found that the customer's water conductivity was outside of the specified range.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable triglycerides results for 2 patient samples on a cobas 8000 c702 module.The customer questioned the high initial results as they did not match the patient's previous results and the cholesterol and glucose results, which prompted them to repeat the samples.Sample 1 had an initial result of 213 mg/dl.The sample was repeated on another c 702 analyzer and the result was 148 mg/dl.Sample 2 had an initial result of 305 mg/dl.The sample was repeated on another c 702 analyzer and the result was 168 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Based on the available data, a general reagent issue could be excluded.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: 23037276
• Report Number: 1823260-2025-02855
• Device Sequence Number: 18505370
• Product Code: CDT
• UDI-Device Identifier: 04015630925117
• UDI-Public: 04015630925117
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 04/30/2026
• Device Catalogue Number: 05171407190
• Device Lot Number: 87342801
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/16/2025
• 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