MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECTRODE CHLORIDE CL/ISE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03003523001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer complained of high results for multiple patients tested for chloride (cl) on two cobas integra 400 plus instruments with serial numbers (b)(4).The customer provided data for 11 patient samples tested on the integra 400 plus instruments compared to a cobas 8000 ise module.Based on the data provided, the results for 3 patient samples were discrepant.It is not clear if this data was generated for diagnostic purposes or if it was generated for troubleshooting only.Clarification on this was requested but not provided.Patient 1 initial cl result on an integra 400 plus instrument was 103 mmol/l.The repeat result from the ise module was 103 mmol/l.Patient 2 initial cl result on an integra 400 plus instrument was 112 mmol/l.The repeat result from the ise module was 101 mmol/l.Patient 3 initial cl result on an integra 400 plus instrument was 113 mmol/l.The repeat result from the ise module was 102 mmol/l.It is not clear which integra 400 plus instrument serial number was used for the initial tests.Both instruments used the same cl electrode lot number.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer said there were no problems with qc; however, the results provided appeared to be too high.The customer noticed calibration variations on both instruments for cl.There were no issues with sodium or potassium.An ise check was performed on both instruments.Based on these results, maintenance was performed along with an additional ise check.The reference cartridge for integra 400 plus serial number (b)(4) was changed as it had been installed in 2017.Pipes and towers had been replaced in (b)(6) 2018.After replacing the reference cartridge, the customer got the high cl results on integra 400 plus serial number (b)(4).Based on this, the customer decided to change the cl electrode on both instruments to lot number 2158847.After the new cl electrode was installed, qc results were better and calibrations were more stable for integra 400 plus serial number (b)(4).Calibration variations were still noticed on integra 400 plus serial number (b)(4).The field service engineer (fse) visited the customer site and performed preventive maintenance on integra 400 plus serial number (b)(4).The customer performed a 2nd comparison between the integra 400 plus instruments and the cobas 8000 ise module.The results compared well to one another.The fse revisited the customer site on 24-jul-2018 to check the customer's water quality.The root cause of the issue was the cl electrode and the glue used to attach the membrane to the electrode housing.The glue caused the membrane to not be properly fixed to the electrode.When the customer replaced the cl electrode, the results were within specification.
Additional Manufacturer Narrative
It was clarified that the discrepant patient data was for troubleshooting purposes only and was not being used for diagnostic purposes.

• Brand Name: ELECTRODE CHLORIDE CL/ISE
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7772495
• Report Number: 1823260-2018-02675
• Device Sequence Number: 1012244
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 03003523001
• Device Lot Number: 21581447
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1