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

Catalog Number	03039773190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable cholesterol gen.2 results for two patient samples tested on a cobas integra 400 plus w/o ise.On (b)(6) 2025: the initial result was 383 mg/dl.The first repeat result was 186 mg/dl.The second repeat result was 188 mg/dl.On (b)(6) 2025: the initial result was 350 mg/dl.The first repeat result was 182 mg/dl.This result was deemed correct and reported.The second repeat result was 183 mg/dl.
Additional Manufacturer Narrative
The cobas integra 400 plus w/o ise serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the calibration and qc results, and the results were within the specified ranges; a general reagent or analyzer issue can be excluded.The sample probe was replaced twice and was reported to be contaminated ten days after replacement.The field service engineer performed troubleshooting and maintenance actions that were unrelated to the event.He reviewed the alarm trace and noted "clot detection" and "no fluid detected" errors.The investigation determined the event was due to a preanalytic issue at the customer site (higher sample volume pipetting due to a sporadic contamination of the sample needle with fibrin or cell debris).Preanalytic are within the customer's responsibility.There was no indication of a device malfunction.

• 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: 23644704
• Report Number: 1823260-2025-04830
• Device Sequence Number: 15917328
• Product Code: CHH
• UDI-Device Identifier: 04015630918430
• UDI-Public: 04015630918430
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 01/23/2026

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 03039773190
• Device Lot Number: 85288601
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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 Sex: Unknown