MAUDE Adverse Event Report: Roche Diagnostics Cholesterol Gen.2; enzymatic esterase--oxidase, cholesterol

Catalog Number	03039773190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with cholesterol gen.2 assay on a cobas 4000 c311 stand alone system.Initial result: 418.4 mg/dl.The customer noticed that the initial result was high.No questionable result was reported outside the laboratory, and the sample was repeated.Repeat result: 218.5 mg/dl.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The cobas 4000 c311 stand alone system serial number was (b)(6).The qc was acceptable.The investigation is ongoing.

• Brand Name: Cholesterol Gen.2
• Common Device Name: enzymatic esterase--oxidase, cholesterol
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50870258
• Report Number: 1823260-2026-03907
• Device Sequence Number: 18820401
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K031824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Catalogue Number: 03039773190
• Device Lot Number: 93818201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• 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