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

Catalog Number	08057630190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they receive questionable results for an unspecified number of patient samples tested with ethanol gen.2 on a cobas c 503 analytical unit.The customer stated that the questioned results are from patients who has physical symptoms of alcohol intoxication.Qualitative breath alcohol concentration (breathalyzer) measurements of these patients are positive.One hour after the breathalyzer measurements, samples are collected from these patients and have ethanol results from the c 503 analyzer that are below the measuring range of the assay.The customer provided specific examples for two patients.On 08-mar-2025, the first patient was observed to be apparently intoxicated.The facility administered breathalyzer testing with a cdp7000 breathalyzer and the result was 62 mg/100 ml of alcohol.Five minutes later, the breathalyzer was repeated and the result was 44 mg/100 ml of alcohol.A venous sample was collected from the patient and measured on the c 503 system, resulting in an ethanol value of < 10 mg/dl.On (b)(6) 2025, the second patient was observed to be apparently intoxicated.The facility administered breathalyzer testing with a cdp7000 breathalyzer and the result was 25 mg/100 ml of alcohol.Five minutes later, the breathalyzer was repeated and the result was 31 mg/100 ml of alcohol.A venous sample was collected from the patient and measured on the c 503 system, resulting in an ethanol value of < 9.30 mg/dl with a data flag (< 10 mg/dl).
Additional Manufacturer Narrative
Calibration and control data were acceptable.A general reagent lot specific issue is not likely.A review of alarm trace data showed a noticeable amount of abnormal aspiration and sample short alarms on the day of the event.These alarms indicate possible sample handling related issues.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.The investigation did not identify a product problem.

• 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
• MDR Report Key: 24270727
• Report Number: 1823260-2026-00411
• Device Sequence Number: 21511452
• Product Code: DIC
• UDI-Device Identifier: 07613336121221
• UDI-Public: 07613336121221
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 08057630190
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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: Male