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

Catalog Number	10825441001
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for potassium electrode (k) on a cobas 6000 c (501) module.Patient 1 initial k result was 6.1 mmol/l.This result did not correspond to the patient¿s previous k result, and the sample was repeated.The repeat result was 5.0 mmol/l.Patient 2 initial k result was 6.5 mmol/l.The customer noticed that qc failed after the initial result and repeated the sample.The repeat result was 5.91 mmol/l.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).On 14-apr-2025, the customer wiped the electrodes, primed the reagents, and performed an ise check.On 15-apr-2025, the customer replaced the fluids and the electrodes and performed an ise check.Calibration and qc were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Qc was acceptable.No issues were identified during a review of the alarm trace data.The field service engineer (fse) could not find a cause for the event.A hardware check was performed, and no issues were identified.Precision study results were within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21969252
• Report Number: 1823260-2025-01398
• Device Sequence Number: 20936250
• Product Code: CEM
• UDI-Device Identifier: 07613336227770
• UDI-Public: 07613336227770
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/30/2025

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 Catalogue Number: 10825441001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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: 82 YR
• Patient Sex: Male