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

Catalog Number	03183777190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus analyzer serial number was (b)(6).The field service engineer (fse) did the following actions: checked the calibrator and found that the used lot number did not match the lot number defined on the device.Checked the calibration and qc and found that they were within acceptable limits.The external water tank was cleaned.The fse performed the checks, calibration, qc, and samples' testing, and the results were all acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 6 patients' samples tested for ethanol gen.2 (etoh2) assay on a cobas integra 400 plus analyzer.Sample 1: initial result: 10.0 mg/dl.1st repeat result: 5.4 mg/dl.Sample 2: initial result: 9.0 mg/dl.1st repeat result: 4.7 mg/dl.On (b)(6) 2025: 2nd repeat result: 3.8 mg/dl.Sample 3: initial result: 10.1 mg/dl.1st repeat result: 5.3 mg/dl.On (b)(6) 2025: 2nd repeat result: 3.9 mg/dl.Sample 4: initial result: 9.2 mg/dl.1st repeat result: 5.0 mg/dl.On (b)(6) 2025: sample 5: initial result: 11.7 mg/dl.Repeat result: 1.0 mg/dl.Sample 6: initial result: 13.3 mg/dl.Repeat result: 3.1 mg/dl.The customer questioned the initial results.No questionable results were reported outside the laboratory, and the samples were repeated.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The preventive maintenance was performed on (b)(6) 2025.The monthly maintenance was up to date.The alarm trace was provided for the day of the event and showed 2 fluid alarms.A general reagent issue can be excluded since calibration and qc data were acceptable.The issue was resolved after replacing the reagent pack with a new lot number.The field service engineer (fse) proactively replaced the probe set and performed a pipetting accuracy check on 23-jul-2025.The investigation did not identify a product problem.Although the root cause could not be determined, it was consistent with either deterioration of the reagent cassette due to handling/storage/transport, or sample handling issues.

• 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: 22574602
• Report Number: 1823260-2025-02240
• Device Sequence Number: 9784631
• Product Code: DIC
• UDI-Device Identifier: 04015630918959
• UDI-Public: 04015630918959
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 09/11/2025

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: 07/31/2025
• Device Catalogue Number: 03183777190
• Device Lot Number: 85056401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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