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

Catalog Number	07005717190
Medical Device Problem Codes	Chemical Problem (2893); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ldl-cholesterol gen.3 results for one patient sample tested on a cobas 8000 cobas c 502 module when compared to the beckman coulter au5800 module.The initial result on the c 502 was 0.95 mmol/l.The repeat result on the au5800 was 2.92 mmol/l.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer indicated that calibration and quality control over time were within the expected range.The investigation determined the issue was likely due to the presence of a biological interference of the analyte.Per the method sheet, "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." no product problem was identified.

• 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: 22805848
• Report Number: 1823260-2025-02487
• Device Sequence Number: 9063848
• Product Code: LBR
• UDI-Device Identifier: 04015630934584
• UDI-Public: 04015630934584
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 10/17/2025

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 Catalogue Number: 07005717190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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