MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CHOLESTEROL GEN.2; ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Catalog Number	03039773190
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
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 cholesterol 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 ldl assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the hdl assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the triglycerides assay.Initial results: (b)(6).Repeat results: (b)(6) repeat results after a 1:10 manual dilution: (b)(6).
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Qc and calibration were acceptable.The serum sample showed no visual abnormalities regarding hemolysis, lipids, or fibrin clots.The instrument was confirmed to be performing without issues.No maintenance work was performed on the unit during this period.The customer later confirmed that the issue was due to a lab internal handling error with dilutions.The investigation did not identify a product problem.

• Brand Name: CHOLESTEROL GEN.2
• Common Device Name: ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
• 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: 24756819
• Report Number: 1823260-2026-01212
• Device Sequence Number: 9138222
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031824
• 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: 03039773190
• 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