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

Catalog Number	21029355001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas integra 400 plus analyzer is (b)(6).The field service engineer determined the failure was related to the potassium electrode.The electrode was replaced.The calibration passed.All checks passed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the potassium electrode on a cobas integra 400 plus.The sample initially resulted in a potassium value of 7.4 mmol/l, with a data flag indicating the ise was unstable.The sample was automatically repeated, resulting in a potassium value of 8.5 mmol/l with a data flag.The customer re-calibrated the ise tests, but calibration failed for potassium.The customer tried replacing the ise mix tower, primed the ise calibrators, and activated the electrodes, but the potassium calibration still failed.Due to the calibration failure, the sample was repeated at another laboratory.The patient sample was sent to another laboratory for testing on an unknown analyzer, resulting in a potassium value of 4.4 mmol/l.The repeat value was deemed correct.
Additional Manufacturer Narrative
Calibration and controls were acceptable.There was no indication of a reagent performance issue.The investigation determined the service actions resolved the issue.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: POTASSIUM ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): AVL SCIENTIFIC CORP.; 33 mansell court; roswell GA 30076
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18738232
• Report Number: 1823260-2024-00485
• Device Sequence Number: 17949286
• Product Code: CEM
• UDI-Device Identifier: 04015630918737
• UDI-Public: 04015630918737
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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 Expiration Date: 09/22/2023
• Device Catalogue Number: 21029355001
• Device Lot Number: 21525047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 10/16/2025
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/13/2024; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male