MAUDE Adverse Event Report: Roche Diagnostics LDL-Cholesterol Gen.3; System, Test, Low Density, Lipoprotein

Catalog Number	08057966190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ldl-cholesterol gen.3 results from the cobas c 503 analytical unit.One example was provided of an initial result of 11.3 mg/dl, and a repeat result of 122 mg/dl.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.

• Brand Name: LDL-Cholesterol Gen.3
• Common Device Name: System, Test, Low Density, Lipoprotein
• 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: 50914631
• Report Number: 1823260-2026-03971
• Device Sequence Number: 5344817
• Product Code: LBR
• UDI-Device Identifier: 07613336121375
• UDI-Public: 07613336121375
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143691
• 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): 09/28/2026

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: 08057966190
• Device Lot Number: 917930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• 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