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

Catalog Number	08445672190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro c 503 analytical unit serial number is (b)(6).The investigation included a review of the calibration, qc data, and alarm trace: the calibration results are within specifications.The qcs are within the specified ranges.The alarm trace does not indicate any issues on the date of event, but has several abnormal aspiration and sample short alarms outside the date of event.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ethanol gen.2 results from two patient samples tested on the cobas c 503 analytical unit.On (b)(6) 2025: patient sample 1 the initial result from the analyzer was -0.00878 g/l with an invalidating data flag.This result was reported as <0.1 g/l.The repeat result from another c 503 analyzer was <0.1 g/l.On (b)(6) 2025: patient sample 2 the initial result from the analyzer was 0.0439 g/l with an invalidating data flag.The repeat result from the analyzer was -0.00110 g/l with an invalidating data flag.The results do not agree with the patients' clinical presentation of acute alcohol intoxication.
Additional Manufacturer Narrative
The investigation reviewed the reaction monitors; there seemed to be no reaction after the third reagent was added.Patient sample 1 - the customer stated that a sample mismatch may have caused this event.Patient sample 2 - the patient sample was sent to another laboratory, and the repeat result of the alcohol assay was negative, which confirmed the reported ethanol gen.2 result.A general related issue is unlikely because calibration and qc data are acceptable.The investigation determined the event was consistent with a patient sample mismatch and 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: 22576453
• Report Number: 1823260-2025-02242
• Device Sequence Number: 9439084
• Product Code: DIC
• UDI-Device Identifier: 07613336157817
• UDI-Public: 07613336157817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/13/2025

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: 01/31/2026
• Device Catalogue Number: 08445672190
• Device Lot Number: 88727701
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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