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

Catalog Number	10825468001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro ise analytical unit serial number was (b)(6).The field service engineer found there was a bad calibration.He recalibrated the ise assays, and the customer cleaned the sample probe.He ran mechanism checks, calibration, qc, and precision, which were successful and within specifications.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable sodium results from the cobas pro ise analytical unit.The samples were repeated on another cobas pro ise analyzer with results in the normal range.Sample 1 initial result was 132 mmol/l, and the repeat result was 138.4 mmol/l.Sample 2 initial result was 133 mmol/l, and the repeat result was 139.3 mmol/l.Sample 3 initial result was 131 mmol/l, and the repeat result was 137.8 mmol/l.Sample 4 initial result was 131 mmol/l, and the repeat result was 137.9 mmol/l.Sample 5 initial result was 125 mmol/l, and the repeat result was 131.8 mmol/l.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The analyzer alarm trace contained abnormal aspiration and sample short errors for the sample probe.These are indicators of possible poor sample quality.The provided centrifugation spin time may be shorter than recommended, and the spin speed may be faster than recommended according to the tube manufacturer¿s recommended guidelines.Correct pre-analytic sample handling is within the customer's responsibility.The investigation determined that the issue was resolved by service actions of recalibration and probe cleaning.

• Brand Name: 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: 23714997
• Report Number: 1823260-2025-04943
• Device Sequence Number: 16021127
• Product Code: JGS
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 01/09/2026

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 Expiration Date: 05/26/2026
• Device Catalogue Number: 10825468001
• Device Lot Number: EDL
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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