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

Catalog Number	08057877190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The calibration and qc were acceptable.A general reagent issue was excluded.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable hdl-cholesterol gen.4 results for 1 patient on a cobas c 303 analytical unit.The initial result was 15.5 mg/dl.The result was considered to be too low and the sample was repeated.On (b)(6) 2025, the repeated result was 14.8 mg/dl.Both values were questioned as the patient's expected result was 30 mg/dl.The sample was sent to another laboratory (method unknown) to be tested, and the result was 25 mg/dl.The patient's cholesterol result was 156 mg/dl, the ldl result was 94.0 mg/dl, and the triglyceride result was 225 mg/dl.The physician did not agree with the hdl results based on the patient's clinical history.
Additional Manufacturer Narrative
The data provided showed "abnormal sample aspiration" alarms.The investigation did not identify a product problem.The investigation determined the issue was consistent with a pre-analytical handling problem.

• 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: 22383432
• Report Number: 1823260-2025-02019
• Device Sequence Number: 17926720
• Product Code: LBS
• UDI-Device Identifier: 07613336121306
• UDI-Public: 07613336121306
• 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): 08/20/2025

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: 03/31/2026
• Device Catalogue Number: 08057877190
• Device Lot Number: 79494601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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 Age: 81 YR
• Patient Sex: Female