MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Catalog Number	03157334001
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na, k, and cl electrodes' lot numbers and expiration dates were not provided.Qc was within the assigned ranges on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ion-selective electrode (ise) results for 3 patients¿ samples tested on a roche 9180 electrolyte analyzer.Results for the following tests were affected: sodium (na), potassium (k) and chloride (cl).Sample 1: na: initial result: 145.3 mmol/l.Repeat result: 138.6 mmol/l.K: initial result: 1.73 mmol/l.Repeat result: 5.47 mmol/l.Sample 2: cl: initial result: 124.1 mmol/l.Repeat result: 110.1 mmol/l.Sample 3: na: initial result: 152.0 mmol/l.Repeat result: 139.1 mmol/l.The customer questioned the initial results and repeated the samples.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The customer was using an expired chloride electrode at the time of the event (expiration date: (b)(6) 2025.There is no evidence of instrument malfunction as the calibrations and qcs were acceptable.The chloride electrode was slightly above the valid range, and it was replaced.The service log showed obstruction errors on 09-jun-2025, and standard errors on 09-jun-2025 and 10-jun-2025.The customer uses a non-roche reference electrode for the roche reference electrode housing.The field service engineer cleaned and conditioned the instrument, replaced the potassium and expired chloride electrodes, and replaced the standard and reference solutions.The instrument was monitored, and no further issues were observed.The cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.The investigation did not identify a product problem.

• 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: 22478451
• Report Number: 1823260-2025-02110
• Device Sequence Number: 7942562
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/26/2025

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: 06/16/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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