MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECTRODE, CHLORIDE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03110443180
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	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cl electrode expiration date was not provided.The roche 9180 electrolyte analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable chloride (cl) test results for an unspecified number of patients' samples tested on the roche 9180 electrolyte analyzer.The reporter stated that the results did not match the patients' clinical pictures.The reporter provided the following examples of discrepant results: patient 1: initial result: 107.8 mmol/l.Repeat result: 104.8 mmol/l.Patient 2: initial result: 107.4 mmol/l.Repeat result: 103.8 mmol/l.Patient 3: initial result: 111.3 mmol/l.Repeat result: 113.0 mmol/l.Patient 4: initial result: 110.6 mmol/l.Repeat result: 107.4 mmol/l.Patient 5: initial result: 105 mmol/l.Repeat result: 108.3 mmol/l.On (b)(6) 2025: patient 6: initial result: 111.1 mmol/l.Repeat result: 111.2 mmol/l.On (b)(6) 2025: patient 7: initial result: 112.5 mmol/l.Repeat result: 112.2 mmol/l.Patient 8: initial result: 112.9 mmol/l.Repeat result: 113.2 mmol/l.Patient 9: initial result: 112 mmol/l.Repeat result: 112.1 mmol/l.
Additional Manufacturer Narrative
Medwatch field d4 was updated.The calibration was within range.The qc values were in the upper part of the allowed range.The chloride electrode and the reference electrode were valid at the time of the event.The customer performed the required maintenance (daily cleaning and conditioning) and electrode maintenance every week.The customer stated that they used dilution of chlorine in water (chlorinated water) to clean pipes and electrodes.The customer could not provide the material for investigation.No abnormal trends were identified during a review of complaints related to cl electrode lot 31250547.Based on the information provided, the investigation did not identify a product problem.

• Brand Name: ELECTRODE, CHLORIDE
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• 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
• MDR Report Key: 22668196
• Report Number: 1823260-2025-02354
• Device Sequence Number: 20706870
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K963627
• 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): 12/12/2025

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: 03110443180
• Device Lot Number: 31250547
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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 Age: 38 YR
• Patient Sex: Male