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

Catalog Number	21029371001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable ise results for 2 patients' serum samples tested on a cobas integra 400 plus analyzer.Results for the sodium (na) test were affected.Sample 1 (patient 1): initial result: 129.2 mmol/l.Repeat result: 136.9 mmol/l.Sample 2 (patient 2): initial result: 134.3 mmol/l.Repeat result: 143.3 mmol/l.No questionable results were reported outside the laboratory as the customer noticed that the na results were running low.The samples were then repeated and the repeat results were deemed to be correct.
Additional Manufacturer Narrative
The na electrode expiration date was not provided.The cobas integra 400 plus serial number was (b)(6).The na electrode was installed on (b)(6) 2024.The customer stated that qc went out of range 4 times before getting it back within range prior to the event.The field service engineer found that one probe failed.He replaced the na electrode and the probe.Precision studies were performed and they were within specifications.Qc was performed and it was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on (b)(6) 2024 and was acceptable.Qc recovery was within ranges.No indication of a reagent's performance issue.The field service engineer found that the electrode's shelf life was exceeded.The service actions (replacing the na electrode and the probe) resolved the issue.No further issues were reported after the service visit.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19645463
• Report Number: 1823260-2024-01905
• Device Sequence Number: 6632829
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 07/17/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male