MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDLC3; LOW DENSITY LIPOPROTEIN TEST SYSTEM

Catalog Number	07005768190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The investigation is ongoing.
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: 2.32 mmol/l.The customer questioned the initial result as it did not match the patient's clinical diagnosis.No questionable result was reported outside of the laboratory and the sample was then repeated.Repeat result: 6.03 mmol/l (tested on hitachi wako).The repeat result was consistent with the ldl calculation method (friedewald).The customer suspected an interference of lipoprotein x or lp(x).
Additional Manufacturer Narrative
The provided data indicated that the ldlc3 value reflected more closely the true ldl value in the patient sample.The product labeling states: "abnormal liver function affects lipid metabolism; consequently hdl and ldl results are of limited diagnostic value.In some patients with abnormal liver function, the ldl-cholesterol result is significantly negatively biased versus beta quantification result." the investigation did not identify a product problem.The cause of the event was consistent with an interference.

• Brand Name: LDLC3
• 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: 21306656
• Report Number: 1823260-2025-00327
• Device Sequence Number: 18368675
• Product Code: LBR
• UDI-Device Identifier: 04015630934591
• UDI-Public: 04015630934591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/21/2025

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: 01/31/2026
• Device Catalogue Number: 07005768190
• Device Lot Number: 81335901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/21/2025
• 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