MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HDL-CHOLESTEROL GEN.4

Catalog Number	07528566190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).The customer stated that they had elevated qc values while the calibration was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for several patient samples tested with the hdl-cholesterol gen.4 assay on a cobas 6000 c501 module.The reporter stated that the assay results have been higher than normal and were repeatable on the same instrument.They noted discrepancies when the results were compared with the patients' historical data.One example of a questionable result was provided: the initial result was 70 mg/dl.This result did not match the patient's historical data of 40 mg/dl.
Additional Manufacturer Narrative
The provided calibration was acceptable.The provided qc showed that it was elevated.The field service engineer visited the customer's site, downloaded the correct calibrator lot, and re-prepared the calibrator and qc materials.The qc was performed, and the customer confirmed that it was within the range.A general reagent issue can be excluded, as the qc was within the acceptable limits.A general instrument issue can also be excluded, as no issues were reported with other tests.The investigation did not identify a product problem.The cause of the event was consistent with a use error where the customer used water from the vials to reconstitute the qcs and calibrators.The product labeling states: "deionized water is used automatically by the instrument as the zero calibrator.".

• Brand Name: HDL-CHOLESTEROL GEN.4
• Common Device Name: HDL
• 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: 23525834
• Report Number: 1823260-2025-04588
• Device Sequence Number: 9065637
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162593
• 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): 12/17/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 07528566190
• Device Lot Number: 814420
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/17/2025
• 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