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

Catalog Number	07528566190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results with multiple assays for a patient sample tested on the cobas integra 400 plus.This medwatch will apply to the hdl assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the lipase assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cholesterol assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ldl assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the triglycerides assay.Initial results: lipase: 8,859 u/l, cholesterol: 4,074 mg/dl, hdl: 1,611 mg/dl, ldl: 2,077 mg/dl, triglycerides: 3,133 mg/dl.Repeat results: lipase: 4,678 u/l, cholesterol: 167 mg/dl, hdl: 69 mg/dl, ldl: 88 mg/dl, triglycerides: 133 mg/dl.Repeat results after a 1:10 manual dilution: cholesterol: 196 mg/dl, hdl: 80 mg/dl, ldl: 101 mg/dl, triglycerides: 154 mg/dl.

• 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: 24756818
• Report Number: 1823260-2026-01214
• Device Sequence Number: 13036729
• Product Code: LBS
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/08/2026

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: 07528566190
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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 Age: 65 YR
• Patient Sex: Female