MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ETHANOL GEN.2; ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Catalog Number	03183777190
Medical Device Problem Codes	Suction Problem (2170); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ethanol gen.2 reagent lot number is 85879201, and the expiration date is 30-sep-2025.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable ethanol gen.2 result from the cobas 6000 c (501) module.The initial result was 10 mg/dl, accompanied by a data flag.The physician questioned the initial result was the patient noted that the patient was potentially under the influence.A new sample was collected, and the result was over 400 mg/dl.The initial sample was repeated, and the result was 460 mg/dl, which was deemed to be correct.
Additional Manufacturer Narrative
A field service engineer (fse) inspected the unit, verified unit functionality, and performed precision checks on the tests the customer complained about.The precision check was okay.The investigation was unable to determine a direct root cause.The issue appears to be resolved as the performance of the instrument was verified.

• Brand Name: ETHANOL GEN.2
• Common Device Name: ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD
• 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 46250-0457
• MDR Report Key: 22435565
• Report Number: 1823260-2025-02078
• Device Sequence Number: 14241182
• Product Code: DIC
• UDI-Device Identifier: 04015630918959
• UDI-Public: 04015630918959
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 09/30/2025
• Device Catalogue Number: 03183777190
• Device Lot Number: 85879201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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 Sex: Unknown