MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number was 31250747 with an expiration date of 10-oct-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 5 patients' samples tested for sodium (na) on a roche 9180 electrolyte analyzer when compared to a different facility.Discrepant results for 1 patient sample were provided.Sample 1: initial result: 120 mmol/l.Per the customer's guidelines, the customer repeated the sample as it was considered critical low.1st repeat result: 120 mmol/l.2nd repeat result: 119 mmol/l (tested from a 2nd tube).During the evaluation process of a new qc, the customer suspected a fault.The customer then randomly picked up 5 patients' samples, including sample 1, and sent them to a different facility to be repeated.3rd repeat result of sample 1: 141 mmol/l (tested on a cobas pro at a different facility).The repeat results tested at the different facility were deemed to be correct.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The data was requested but not provided.The investigation was concluded prematurely due to the inability to obtain the necessary information.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 22994823
• Report Number: 1823260-2025-02780
• Device Sequence Number: 18495207
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 11/07/2025

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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 11/07/2025
• 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