MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE SODIUM ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number	09237216001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The calibration was acceptable.The field service representative replaced the syringe seals, pinch tubing, sipper and vacuum nozzles, and cleaned the dilution nozzles.He performed checks and tests with acceptable results.Although no cause for the issue was found, the instrument performance was verified, and the issue appears to be resolved.
Event or Problem Description
There was an allegation of questionable ise sodium electrode results for 12 patient samples and questionable chloride electrode results for 1 patient sample on a cobas 8000 ise 1800 module.This medwatch will apply to the ise sodium electrode.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the chloride electrode.Patient 1: the initial na result is 147 mmol/l, and the repeated result was 140 mmol/l.Patient 2: the initial na result is 144 mmol/l, and the repeated result was 134 mmol/l.Patient 3: the initial na result is 152 mmol/l, and the repeated result was 145 mmol/l.Patient 4: the initial na result is 145 mmol/l, and the repeated result was 137 mmol/l.Patient 5: the initial na result is 153 mmol/l, and the repeated result was 146 mmol/l.Patient 6: the initial na result is 150 mmol/l, and the repeated result was 143 mmol/l.Patient 7: the initial na result is 150 mmol/l, and the repeated result was 142 mmol/l.Patient 8: the initial na result is 150 mmol/l, and the repeated result was 142 mmol/l.Patient 9: the initial na result is 151 mmol/l, and the repeated result was 144 mmol/l.Patient 10: the initial na result is 142 mmol/l, and the repeated result was 134 mmol/l.Patient 11: the initial cl result is 112 mmol/l, and the repeated result was 95 mmol/l.Patient 12: the initial na result is 150 mmol/l, and the repeated result was 143 mmol/l.Patient 13: the initial na result is 149 mmol/l, and the repeated result was 141 mmol/l.The samples were repeated due to alarms in the customer's middleware.
Additional Manufacturer Narrative
Section d4 primary udi number was added.

• Brand Name: ISE SODIUM ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• 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: 22013130
• Report Number: 1823260-2025-01479
• Device Sequence Number: 7984952
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 09237216001
• Device Lot Number: ASKU
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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