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

Catalog Number	05168538190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cholesterol gen.2 results for 1 patient sample on a cobas 8000 c702 module.The initial result was 0.25 mmol/l.The sample was repeated and the result was 3.9 mmol/l.The sample was tested 10 times and the average result was 3.973 mmol/l.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025, and was acceptable.The qc recovery data provided was acceptable.The patient sample tube showed many red blood cells and bubbles in the gel separation layer, indicating possible pre-analytical issues with sample quality.The field service engineer (fse) cleaned and checked the sample probe.The service maintenance actions performed by the fse resolved the issue.

• 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: 23097623
• Report Number: 1823260-2025-03205
• Device Sequence Number: 15607810
• Product Code: CHH
• UDI-Device Identifier: 04015630924967
• UDI-Public: 04015630924967
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/19/2025

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: 12/31/2025
• Device Catalogue Number: 05168538190
• Device Lot Number: 86133501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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: 41 YR
• Patient Sex: Male