MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COBAS 501E; TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM

Model Number CEE (C501)

Device Problems Incorrect Or Inadequate Test Results (2456); Environmental Compatibility Problem (2929)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

Beginning with the start up in the am for midnight shift, we started having qc issues with calciums on the ce to the point we could not get the qc to work at all.Roche hotline was contacted and multiple procedures (cleans, flushes, recal's, reagent dumps, etc.) were tried.Nothing fixed it.When day shift attempted their start up on the other analyzer (cee), we experienced the same issue.When we called service, we were told that the water coming into the analyzers could be a potential cause for the problem.Service did come in and dumped and cleaned the water bath on the cee, and checked for anything on the instrument that could have caused the issue.But with the problem occurring on both analyzers, we felt strongly it was the water that had caused the problems.We had to dump all calcium packs that had been loaded during that time, as they all had used water for diluting reagents.By the end of day, we were finally able to get qc to work and start reporting pts again.

• Brand Name: COBAS 501E
• Type of Device: TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 4780577
• MDR Text Key: 5880638
• Report Number: 4780577
• Device Sequence Number: 1
• Product Code: JFP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CEE (C501)
• Device Catalogue Number: 05061482190
• Device Lot Number: 609429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Patient Sequence Number: 1
• Treatment: WE HAVE A ROCHE CEE AND CE, AND EVERYTHING WAS IN; LINE AND BOTH WERE IN USE.; USE. THE EVOQUA HAS 2 SYSTEMS SUPPLYING THE ROCHE