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

Catalog Number	10825441001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant results from 2 samples drawn at the same time from 1 patient tested for potassium electrode (k) on a cobas c 303 analytical unit.The initial result was 6.3 mmol/l.This sample was collected with a syringe from the patient¿s iv port.The doctor questioned this result.The customer repeated this sample, and the result was 6.6 mmol/l.Another sample was collected at the same time as the sample from the iv port, and the initial result was 4.35 mmol/l.A new venous sample was obtained, and the result was 4.1 mmol/l.The customer repeated this sample, and the result was 4.28 mmol/l.The result of 4.1 mmol/l was believed to be correct.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025 with no issues.There were no issues with qc.No issues were identified during a review of the alarm trace data.The new sample for this patient produced expected results.Based on the information provided, 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22044977
• Report Number: 1823260-2025-01542
• Device Sequence Number: 12981867
• Product Code: CEM
• UDI-Device Identifier: 07613336227770
• UDI-Public: 07613336227770
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/13/2025

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: DHA10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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