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

Catalog Number	08057966190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable ldl-cholesterol gen.3 result from one patient sample tested on the cobas c 503 analytical unit.On (b)(6) 2025: the initial result from the module was 1.39 mmol/l.The repeat result at 1:2 dilution was 0.956 mmol/l with a final calculated dilution result of 1.912 mmol/l.The repeat result at 1:10 dilution was 0.173 mmol/l with a final calculated dilution result of 1.73 mmol/l.On (b)(6) 2025: the repeat result from the module was 1.96 mmol/l.On (b)(6) 2025: the repeat result from an architect analyzer was 4.44 mmol/l.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
B7 other relevant history was updated.The investigation included a review of the data set provided by the customer: the ldl cholesterol gen.3 calibration and qc results were within the specified ranges.The alarm trace contained multiple aspiration errors and an insufficient sample error.Based on the information provided, the investigation determined that the event was consistent with a typical fredrickson type iii (hyperlipoproteinemia type iii).Typically, cholesterol and triglycerides are approximately equal, and there's a discrepancy between total cholesterol and ldl+hdl due to a high proportion of remnant ldl (b-vldl), which is intentionally masked in a direct ldl test.The hdl is typically low.The architect analyzer's result obviously masks vldl less effectively than roche's ldl cholesterol gen.3, which is why it (incorrectly) measures ldl at a higher level, yet the total cholesterol still doesn't match the hdl+ldl result.A general reagent problem was ruled out, as the calibration and qc results are acceptable.The investigation did not identify a product problem based on the provided data.

• 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: 23655738
• Report Number: 1823260-2025-04860
• Device Sequence Number: 18672868
• Product Code: LBR
• UDI-Device Identifier: 07613336121375
• UDI-Public: 07613336121375
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/19/2026

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: 87041001
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/19/2026
• 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