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

Catalog Number	05967104190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable ethanol gen.2 result for one patient tested on a cobas 8000 c702 module.The initial result was reported to the emergency room.The doctor questioned the result as the patient smelled of alcohol and the patient's companion confirmed the amount of alcohol the patient took, prompting the reporter to rerun the qc and the patient sample.The initial result with the patient sample in a sample cup was 6.5 mg/dl (negative).The first repeat result using the primary tube was >300 mg/dl (326.3 mg/dl).The second repeat with the patient sample in a sample cup was >300 mg/dl (336.3 mg/dl).The result of a new patient sample was >300 mg/dl (309.7mg/dl).
Additional Manufacturer Narrative
The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
In the initial mdr, the first line of b5 describe event or problem should have been: "the initial reporter received a questionable ethanol gen.2 result for one patient sample tested on a cobas 8000 c702 module." instead of: "the initial reporter received a questionable ethanol gen.2 result for one patient tested on a cobas 8000 c702 module." the reported module is no longer installed as it was a transitory instrument for a new cobas pro analyzer.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19182805
• Report Number: 1823260-2024-01279
• Device Sequence Number: 7280532
• Product Code: DML
• UDI-Device Identifier: 04015630927678
• UDI-Public: 04015630927678
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K952839
• 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): 05/22/2024

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: 05967104190
• Device Lot Number: ASKU
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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