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

Catalog Number 03183777190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer stated that ethanol controls were out of range and the issue was caused by the replaced reagent pack.The customer ran controls after replacing the pack; controls recovered within the customer's established ranges.The investigation determined the issue was resolved by the service actions.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with etoh2 ethanol gen.2 on a cobas 6000 c (501) module.No incorrect results were reported outside of the laboratory.The reporter replaced the ethanol reagent pack and repeated the samples.The reporter also noted there were bubbles in the analyzer cuvettes.The first sample initially resulted with an ethanol value of 30 mg/dl, which repeated as 0.7 mg/dl.The repeat value was believed to be correct.The second sample initially resulted with an ethanol value of 8, which repeated as 0.0.The c501 analyzer serial number is (b)(4).

• Brand Name: ETHANOL GEN.2
• Type of Device: 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: 10137454
• MDR Text Key: 203353172
• Report Number: 1823260-2020-01403
• Device Sequence Number: 1
• Product Code: DML
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 03183777190
• Device Lot Number: 46002501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1