MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT NA, K, CI FOR GEN.2; REFERENCE ELECTRODE

Model Number COBAS 8000 ISE

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).

Event Description

The customer complained of questionable results for ise indirect na and ci for gen.2 for one patient sample.Of the data provided only the result for chloride is a reportable malfunction.The initial chloride result was 71 mmol/l with a repeat result of 106 mmol/l.The repeat testing was performed on the other ion selective electrode unit on the same cobas 8000 cobas ise module (double) system.The repeat result was deemed to be correct.The initial chloride result was reported outside of the laboratory.There was no adverse event.The lot number and expiration date for the chloride electrode was requested but not provided.The sample was processed by a modular pre-analytics system.The field engineering specialist found buildup around the mixing vessel.He cleaned the buildup that he found along the mixing vessel, along with the cleaning and checking of other components.He ran precision checks which were acceptable.The customer ran calibration and qc which all passed.

Manufacturer Narrative

The initial service visit did not resolve the issue as originally stated.A second service visit had to be dispatched as the customer had another similar issue.During the follow up service visit, the field engineering specialist found a defective reference electrode.He replaced the defective electrode along with all other electrodes.He replaced the pinch valve tubing.He visually inspected the system along with cleaning the vacuum line.He performed a precision check which passed.The customer calibrated and performed qc which passed.The customer stated that they have had no further issues with their ion selective electrode (ise).Unique identifier (udi)# (b)(4).

• Brand Name: ISE INDIRECT NA, K, CI FOR GEN.2
• Type of Device: REFERENCE ELECTRODE
• 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: 6854831
• MDR Text Key: 86455671
• Report Number: 1823260-2017-01948
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• 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,Followup
• Report Date: 09/20/2017

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
• Device Operator: Health Professional
• Device Model Number: COBAS 8000 ISE
• Device Catalogue Number: 03149501001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/20/2017
• 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