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

Catalog Number 03003523001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas integra 400 plus is (b)(6).The investigation reviewed the na calibration and qcs; the results were within specifications.The field service engineer (fse) noted that the na electrode was replaced 3 weeks ago and the k and cl electrodes were replaced 2 days ago.The fse replaced the cl electrode with the previous cl electrode used.The customer performed calibration and qcs with acceptable results; patient sample results from the analyzer corresponded with the results from their backup analyzer.The investigation determined that the event was caused by the cl electrode.This issue has been addressed.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

Event Description

The initial reporter received questionable ise indirect na for gen.2 results from an unspecified number of patient samples tested on the cobas integra 400 plus.The reporter stated their sodium results were too low.The reporter was able to provide two samples from one patient with questionable results.The reporter stated that the results did not match the expected results and the clinical status of the patient.On an unknown date, the result of the first sample was 141 mmol/l.On (b)(6) 2023, the result of the second sample was 130 mmol/l.

Manufacturer Narrative

Medwatch fields d.Device identification and g4 pma / 510k (premarket numbers) have been updated.

• Brand Name: CHLORIDE ELECTRODE
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18260793
• MDR Text Key: 329815389
• Report Number: 1823260-2023-03835
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (y/n): Y
• Reporter Country Code: WZ
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 03003523001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/19/2024
• 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
• Patient Sequence Number: 1