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

Catalog Number	03111628180
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas b 221 4 roche omni s4 system serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable potassium results from the cobas b 221 4 roche omni s4 system.The samples were repeated after the customer cleaned the analyzer.Patient 1 initial result was 10.84 mmol/l, and the repeat result was 4.63 mmol/l.Patient 2 initial result was 6.82 mmol/l, and the repeat result was 3.8 mmol/l.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation determined that the event was consistent with a preanalytical issue at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.A review of the provided calibration, qc, and analyzer data did not indicate any issues.There is no evidence to suggest a malfunction of the device.

• 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: 22726604
• Report Number: 1823260-2025-02409
• Device Sequence Number: 18247389
• Product Code: CEM
• UDI-Device Identifier: 04015630014293
• UDI-Public: 04015630014293
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 03111628180
• Device Lot Number: 31250547
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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