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

Catalog Number	08057877190
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c503 analytical unit serial number was (b)(6).The calibration and qc were acceptable on the day of the event.The alarm trace showed multiple abnormal aspiration alarms and cell blank alarms on the day of the event.The customer performed monthly maintenance and changed the lamp and the reaction cells.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested for hdl-cholesterol gen.4 (hdlc4) assay on a cobas c503 analytical unit.Initial result: 3.35 mg/dl.The customer questioned the initial result and repeated the sample.Repeat result: 92.80 mgdl.The repeat result of 92.8 mgdl was deemed to be correct.No questionable result was reported to the patient.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.

• Brand Name: HDL-CHOLESTEROL GEN.4
• Common Device Name: HDL CHOLESTEROL 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22124149
• Report Number: 1823260-2025-01691
• Device Sequence Number: 7505713
• Product Code: LBS
• UDI-Device Identifier: 07613336121306
• UDI-Public: 07613336121306
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/25/2025

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: 07/31/2026
• Device Catalogue Number: 08057877190
• Device Lot Number: 821022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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