MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDL-CHOLESTEROL GEN.3; LOW DENSITY LIPOPROTEIN TEST SYSTEM

Catalog Number	07005768190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with ldl-cholesterol gen.3 (ldlc3) assay on a cobas 8000 c702 module.Initial result: 0.4 mg/dl.The customer noticed that the initial result was <3.8 mg/dl and it was auto-validated by the infinity.Repeat result: 155.6 mg/dl.Reportedly, the repeat result was as expected.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Calibration and qc were acceptable.The field application specialist visited the customer's site on the day of the event and set a new rule in infinity for the repetition of low results.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem based on the information provided.The cause of the event could not be determined.

• Brand Name: LDL-CHOLESTEROL GEN.3
• Common Device Name: LOW DENSITY LIPOPROTEIN TEST SYSTEM
• 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: 21433245
• Report Number: 1823260-2025-00515
• Device Sequence Number: 11897427
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143691
• 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): 03/18/2025

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: 07005768190
• Device Lot Number: 833054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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