MAUDE Adverse Event Report: Roche Diagnostics Cholesterol Gen.2; Cholesterol, enzymatic

Catalog Number	08057443190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable cholesterol gen.2 results from the cobas c 503 analytical unit.The initial result was 3.41 mg/dl, and the repeat result was 295 mg/dl.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The field service engineer found that the lamp was not fully extended.He fully extended the lamp mechanism to seat against the incubation disk.Abnormal aspiration alarms were present in the analyzer alarm trace.Therefore, a pre-analytical issue cannot be excluded.The investigation is ongoing.

• Brand Name: Cholesterol Gen.2
• Common Device Name: Cholesterol, enzymatic
• 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: 50821000
• Report Number: 1823260-2026-03848
• Device Sequence Number: 15990538
• Product Code: CHH
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 08057443190
• Device Lot Number: 934751
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/18/2026
• 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