MAUDE Adverse Event Report: ROCHE DIAGNOSTICS K ELECTRODE; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number ASKU

Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516); Improper Chemical Reaction (2952)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas 8000 ise module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received questionably high ise results for an unspecified number of patient samples tested on a cobas 8000 ise module.The customer provided an example of one patient sample with discrepant k electrode results.The sample initially resulted in a k value of 5.6 mmol/l.The sample was repeated since the customer noticed an abnormally high number of high sodium results.The sample was repeated and resulted in a k value of 4.5 mmol/l.The repeat value was deemed correct.

Manufacturer Narrative

The field service engineer had the customer inspect the sample probe and it was found to have remnants of gel on the tip of the probe.The customer replaced the probe.Controls and patient samples were then tested with no issues.The investigation determined the customer's actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: K ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18343783
• MDR Text Key: 331072255
• Report Number: 1823260-2023-04060
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1