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

Catalog Number	21029371001
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	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode in question was installed on 02-oct-2023.Its expiration date was not provided.The old na electrode has been in use since 08-may-2023 and had a lot number of 21524947.The cobas integra 400 plus serial number was (b)(6).The ise tubing was replaced on 16-aug-2023 as part of the preventive maintenance.Calibration and qc were within the expected ranges.There were no significant alarms observed on the day of sample testing.The provided pre-analytics information showed that the sample quality was good.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for unspecified patients' samples tested with sodium (na) assay on a cobas integra 400 plus analyzer compared to testing with the old na electrode that was previously in use.Only 1 patient's sample was re-tested and provided after the electrode replacement.At 08:56 a.M.The sample was tested multiple times on a different cobas integra 400 plus analyzer resulting in na values of 139.0 mmol/l, 139.2 mmol/l, 138.6 mmol/l, 138.6 mmol/l, 138.7 mmol/l, 138.6 mmol/l, 139.8 mmol/l, 138.7 mmol/l, 138.1 mmol/l.At 10:41 a.M.The sample was tested multiple times and the results were: 125.5 mmol/l, 126.1 mmol/l, 127.1 mmol/l, 126.8 mmol/l, and 125.7 mmol/l.The old electrode was re-installed and the sample was then repeated multiple times.At 11:54 a.M.The repeat results were: 141.5 mmol/l, 139.3 mmol/l, 140.1 mmol/l, 139.9 mmol/l, and 141.8 mmol/l.The result released to the patient and the physician was 139.0 mmol/l obtained from the other cobas integra 400 plus system.
Additional Manufacturer Narrative
The na electrode was replaced by a re-installed one.The workaround action (replacing the na electrode) resolved the issue.The investigation identified a degradation issue.The root cause was consistent with a component failure of a newly installed na electrode.

• 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: 18072550
• Report Number: 1823260-2023-03524
• Device Sequence Number: 20773207
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 02/07/2024

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: 21530547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 37 YR
• Patient Sex: Male