MAUDE Adverse Event Report: ROCHE DIAGNOSTICS UREA/BUN; UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Catalog Number 04460715190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Event Description

The customer received questionable high ureal urea/bun patient results from cobas c501 serial number (b)(4) when they started using a new lot number of reagent.They calibrated the reagent pack and ran qc, but it was out of range high.After several attempts, they loaded a new reagent pack of the same lot, calibrated, and qc was then ok.They tested one patient on this analyzer and on another cobas c501 analyzer and it was good so they started running patient samples.The customer then noticed three patient results that were high when compared to the other cobas c501.Of the data provided, the results for two samples were discrepant.Sample 1 original estimated result was 50 mg/dl and the result on the other analyzer was 25 mg/dl.Sample 2 original result was 120 mg/dl with a data flag, the automatic repeat result with a dilution was 123 mg/dl.The repeat result on the other analyzer was 60 mg/dl.The erroneous results were reported outside the laboratory.The repeat results from the other analyzer were believed to be correct.The patients were not adversely affected.The field service representative found the cause was the bun reagent cassette.Upon his arrival onsite, the customer informed him that she had replaced the cassette.Bun samples were then running fine and comparing with other c501 analyzer.The tech performed precision testing which looked good.The calibration was good and qc was within the specifications.Further investigation confirmed the issue was resolved by using a new reagent cassette.Contamination of the affected cassette was assumed to be the root cause of this issue.

• Brand Name: UREA/BUN
• Type of Device: UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
• 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: 5969573
• MDR Text Key: 55451660
• Report Number: 1823260-2016-01433
• Device Sequence Number: 1
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 04460715190
• Device Lot Number: 15958901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• 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