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

Catalog Number	07005717190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).The field service engineer inspected the module and did not find any issues.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable ldl-cholesterol gen.3 assay result for one patient sample tested on a cobas 8000 cobas c 502 module.On (b)(6) 2025: the initial result was 102.7 mg/dl.On (b)(6) 2025: the repeat result was 166.8 mg/dl.This result was consistent with the patient's previous findings.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The customer used a clotting time of 20 minutes and a centrifugation time of 8 minutes.These times may be too short.A general reagent issue can be excluded based on the qc data.Service personnel did not identify any instrument issues.The investigation determined the event was consistent with pre-analytical handling issues.

• 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: 23643890
• Report Number: 1823260-2025-04821
• Device Sequence Number: 15985867
• Product Code: LBR
• UDI-Device Identifier: 04015630934584
• UDI-Public: 04015630934584
• 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): 12/18/2025

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 Catalogue Number: 07005717190
• Device Lot Number: 87040801
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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