MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lithium results from the roche 9180 electrolyte analyzer for 8 patients.Patient 1's initial result was 0.76 mmol/l, and the repeat result was 1.15 mmol/l.Patient 2's initial result was 0.20 mmol/l, and the repeat result was 0.94 mmol/l.Patient 3's initial result was 0.30 mmol/l, and the repeat result was 0.57 mmol/l.Patient 4's initial result was 0.28 mmol/l, and the repeat result was 0.51 mmol/l.Patient 5's initial result was 0.39 mmol/l, and the repeat result was 0.68 mmol/l.Patient 6's initial result was 0.26 mmol/l, and the repeat result was 0.66 mmol/l.Patient 7's initial result was 0.97 mmol/l, and the repeat result was 1.27 mmol/l.Patient 8's initial result was 1.45 mmol/l, and the repeat result was 0.40 mmol/l.
Additional Manufacturer Narrative
The lithium reagent lot and expiration date were not provided.Qc was passing at the time of the event.The investigation is ongoing.
Additional Manufacturer Narrative
Updated medwatch field d.Suspect medical device, common device name, product code.
Additional Manufacturer Narrative
A field service engineer (fse) determined that two of the upper tubes were incorrectly connected.The fse resolved the issue by correctly connecting the tubes.However, in an effort to reproduce the issue, our team attempted to exchange the tubes in the roche lab, following the fse's explanation.We were unable to reproduce the original issue.Instead, after exchanging the tubes, no calibration could be performed.A persistent error message, "clog check fluid path," appeared during the calibration process.The investigation was unable to determine a direct root cause.

• 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: 22936804
• Report Number: 1823260-2025-02689
• Device Sequence Number: 9768554
• Product Code: JIH
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/08/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/23/2025
• 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