MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ETHO2; ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Catalog Number	08057630190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with ethanol gen.2 (etoh2) assay on a cobas pro c 503 analyzer.Initial result: 137 mg/dl.The physician questioned the result and the patient denied using alcohol.The sample was rerun.Rerun result: 0 mg/dl the rerun result deemed to be correct.
Additional Manufacturer Narrative
The cobas pro c 503 analyzer serial number was (b)(6).Last calibration was performed (b)(6)2023 was acceptable with no alarms.Qc was performed and was acceptable.There was no indication for a performance issue of the reagent or the instrument.The alarm trace contained 2 sample foam detection alarms which may be an indication of a poor sample quality.The field service engineer (fse) checked the gear and the water pressure and they both were within range.He also checked the rinse levels for the wash stations and the cuvette rinse.Precision studies were performed and they were within specifications.The customer performed qc and it was within the facility's range.The fse did a perfomance check and the instrument was performing within specifications.The issue was resolved.The cause of the event could not be determined.

• Brand Name: ETHO2
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17363018
• Report Number: 1823260-2023-02365
• Device Sequence Number: 5226456
• Product Code: DML
• UDI-Device Identifier: 07613336121221
• UDI-Public: 07613336121221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 09/30/2023
• Device Catalogue Number: 08057630190
• Device Lot Number: 708708
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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