MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 POTASSIUM ELECTRODE; ION SPECIFIC POTASSIUM ELECTRODE

Catalog Number	03110320180
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458); Output Problem (3005); 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 na electrode lot number was 403176.The expiration date was not provided.The k electrode lot number was 468279.The expiration date was not provided.On (b)(6) 2025, the snappak fluid pack was replaced, calibration was performed, qc passed, and a repeatability test was conducted with acceptable results.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for sodium (na) and potassium (k) on a roche 9180 electrolyte analyzer.The initial na result was 151 mmol/l.The repeat result was 133 mmol/l.The initial k result was 4.9 mmol/l.The repeat result was 4.2 mmol/l.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The roche 9180 electrolyte analyzer had a serial number of (b)(6).During a review of the instrument's error codes, several "standard a", "power failure", and "not calibrated" errors were found on different dates.The sodium electrode lot number was 31244047 with an expiration date of 30-may-2025.This electrode was installed on the instrument on 25-jan-2025, with an install before date of 30-may-2025, and was valid at the time of the event.The k electrode was installed on the instrument on 25-jan-2025, with an install before date of 22-sep-2023).The k electrode has an in-use time of 26 weeks; therefore, this electrode expired on 22-mar-2024 and was not valid at the time of the event.The roche reference electrode and electrode housing both expired on 08-mar-2024 and were not valid at the time of the event.After the customer replaced the expired products, qc was acceptable, and the instrument functioned correctly.The investigation did not identify a product problem.The customer was using expired electrodes at the time of the event.

• Brand Name: ROCHE 9180 POTASSIUM ELECTRODE
• Common Device Name: ION SPECIFIC POTASSIUM ELECTRODE
• 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 46250-0457
• MDR Report Key: 22786997
• Report Number: 1823260-2025-02464
• Device Sequence Number: 8236437
• Product Code: CEM
• UDI-Device Identifier: 04015630028689
• UDI-Public: 04015630028689
• Combination Product (Y/N): N
• Initial Reporter Country: NU
• PMA/510(K) Number: K961458
• 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): 11/20/2025

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: 03110320180
• Device Lot Number: 31231047
• 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: 11/03/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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