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

Catalog Number	21029371001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas integra 400 plus is (b)(6).The calibration results had data flags.The qc results had data flags surrounding the date of event.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable na electrode assay results from multiple patient samples tested on the cobas integra 400 plus.The following are examples of discrepant results from the analyzer: sample 1 the initial na result was 132 mmol/l.The repeat result was 139 mmol/l.Sample 2 the initial na result was 132 mmol/l.The repeat result was 138 mmol/l.Sample 3 the initial na result was 134 mmol/l.The repeat result was 140 mmol/l.The initial results were below the reference range, prompting the patient sample reruns.The repeat results were deemed correct.The reporter stated they also received ion-selective electrode (ise) unstable and solution errors.
Additional Manufacturer Narrative
The field service representative remotely assisted the customer in replacing the na electrode, extra activation, and air/water calibration, which resolved the calibration issues.The customer did not report any other issues.The investigation determined that the customer's action (na electrode replacement) resolved the issue.

• Brand Name: ELECTRODE, SODIUM
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21582990
• Report Number: 1823260-2025-00708
• Device Sequence Number: 9217527
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/11/2025

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: 21029371001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/11/2025
• 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