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	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable etoh2 ethanol gen.2 (etoh2) result for one patient sample tested on a cobas 6000 c (501) module with serial number (b)(4).The initial result was reported outside of the laboratory.The result was questioned by the physician who stated that the result did not fit the patient's clinical picture.The reporter used a plasma and serum sample from the patient.On (b)(6) 2022, the initial result of the initial plasma sample from line 2 at 11:08 was 43.3 mg/dl.On (b)(6) 2022, the first repeat result of the initial plasma sample from line 2 at 5:08 was -1.7 mg/dl with a data flag.The second repeat result of the initial plasma sample from line 2 at 5:08 was 0.6 mg/dl with a data flag.The reporter stated that a reagent pack with a low volume of tests was used for these reruns.On (b)(6) 2022, the third repeat result of the initial plasma specimen at 8:57 from line 2 was 2.6 mg/dl.The initial result of a serum specimen at 8:57 from line 2 was 2.6 mg/dl.The reporter stated that he used a new reagent pack in line 2 for these tests.On (b)(6) 2022, the second repeat result of the serum specimen at 9:49 from line 1 was 0.0 mg/dl.The fourth repeat result of the initial plasma specimen at 9:49 from line 1 was -1.0 mg/dl with a data flag.The reporter stated that he used a new reagent pack in line 1 for these reruns.
Additional Manufacturer Narrative
The field service engineer (fse) checked the reagent probe alignment.The investigation is ongoing.
Additional Manufacturer Narrative
The qc data was within specifications.The alarm trace on (b)(6) 2022 did not indicate an issue.The reaction monitors of the reruns did not indicate an issue.No further issues were reported by the customer.  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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14249270
• Report Number: 1823260-2022-01221
• Device Sequence Number: 20087466
• Product Code: DML
• UDI-Device Identifier: 04015630918959
• UDI-Public: 04015630918959
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/17/2022

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: 58433401
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/17/2022
• 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