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

Catalog Number	10825441001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 ise 1800 module serial number is (b)(6).A field service engineer (fse) discovered a possible flow path abnormality and a degraded potassium electrode.The fse completed ion-selective electrode (ise) checks 40 times with no abnormalities.He removed the electrodes and cleaned out the bath cavity and found some dried salt residue on the acrylic block by the reference electrode.They reinstalled the electrodes with a new potassium electrode and replaced the pinch valve tube.Calibration, qc, and a 21-cup precision test were all completed and passed.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable potassium electrode results from the cobas 8000 ise 1800 module.Patient 1's initial result was 6.1 mmol/l, and the repeat result was 4.4 mmol/l.Patient 2's initial result was 5.5 mmol/l, and the repeat result was 3.8 mmol/l.The repeat results were from another analyzer and deemed to be correct.The initial results were questioned because of an alarm code during the run.
Additional Manufacturer Narrative
The investigation determined that the service action resolved the issue.

• 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): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22211325
• Report Number: 1823260-2025-01848
• Device Sequence Number: 8620302
• Product Code: CEM
• UDI-Device Identifier: 07613336227770
• UDI-Public: 07613336227770
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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
• Report Date (Section B): 07/29/2025

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: 03/22/2026
• Device Catalogue Number: 10825441001
• Device Lot Number: DQP91
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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 Sex: Unknown