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	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ldl-cholesterol gen.3 on a cobas c 503 analytical unit.The sample initially resulted in an ldl value of 5.00 mmol/l with a data flag.The sample was automatically repeated, resulting in an ldl value of 5.10 mmol/l with a data flag.These values were held and not released to the patient.The sample was repeated again, resulting in an ldl value of 1.49 mmol/l which was then released to the patient.The sample was repeated afterwards and resulted in a value of 5.07 mmol/l with a data flag.An amended report was issued.
Additional Manufacturer Narrative
A reagent issue is not likely since calibration and controls were acceptable.The main water pump pressure was determined to be high, but is not likely to cause the issue.A review of alarm trace data showed aspiration and abnormal blank alarms, which are indicators of poor sample quality.The field service engineer checked the rinse unit water level adjustment, the rinse tube condition, and probe adjustments.The system was working within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with insufficient pre-analytic sample handling.

• 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 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: 23416805
• Report Number: 1823260-2025-04414
• Device Sequence Number: 13364022
• Product Code: LBR
• UDI-Device Identifier: 07613336121375
• UDI-Public: 07613336121375
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 01/06/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 08057966190
• Device Lot Number: 83806601
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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