MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number was 31244547 with an expiration date of 20-mar-2026.The field service engineer inspected the tubing and found it to be okay.He found crystallization on the edges of the snappak, which was replaced.He performed daily cleaning, a conditioning cycle, calibration, and qc.The customer replaced the electrodes.A reproducibility test was performed, and the results were consistent.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable sodium results from the electrolyte analyzer w/o starterkit 9180.Example 1 initial result was 115 mmol/l, and the repeat results were 136 mmol/l and 137 mmol/l.Example 2 initial result was 114 mmol/l, and the repeat results were 115 mmol/l and 141 mmol/l.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation was unable to determine a specific root cause.However, the issue appeared to be resolved after the service visit.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Common Device Name: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22882784
• Report Number: 1823260-2025-02602
• Device Sequence Number: 9604619
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 09/18/2025

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: 03157334001
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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