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

Catalog Number	03183777190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.Qc was acceptable on the day of the event.The alarm trace showed an abnormal sample probe aspiration alarm.Based on the calibration and qc data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with a pre-analytical sample handling issue.
Event or Problem Description
There was an allegation of questionable etoh2 ethanol gen.2 results for 1 patient sample on a cobas 8000 cobas c 502 module.The initial etoh2 result was 17.4 mmol/l.The first repeat result was 14.8 mmol/l.The sample was repeated on another module and the result was 0.5 mmol/l.The sample was repeated again on the original module and the result was 0.2 mmol/l.Gas chromatography/mass spectrometry (gc/ms) testing was carried out on the sample and the etoh result was <2.The date of testing and the units of measurement were requested but not provided.The initial result was reported outside of the laboratory.The second repeat result and the result from the other module were deemed correct.The analyzer serial number is (b)(4).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16819804
• Report Number: 1823260-2023-01412
• Device Sequence Number: 15235048
• Product Code: DML
• UDI-Device Identifier: 04015630918959
• UDI-Public: 04015630918959
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2023

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 Catalogue Number: 03183777190
• Device Lot Number: 66858801
• 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: 04/03/2023
• Initial Report FDA Received Date: 04/26/2023
• 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 Age: 3 YR
• Patient Sex: Unknown