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

Model Number	I400+
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for 3 patient samples on a cobas integra 400 plus module.The customer was prompted to rerun patient samples due to qc and calibration failures from a new na electrode.For patient 1, the initial na result was 124 mmol/l.The repeat result was 131 mmol/l.The initial result was reported outside of the laboratory.The repeat result was deemed correct.On (b)(6) 2022, the initial na results for patient 2 were 129.3 mmol/l and 129.3 mmol/l.On (b)(6) 2022, the repeat results were 134.4 mmol/l, 134.6 mmol/l, and 133.9 mmol/l.On (b)(6) 2022, the initial na results for patient 3 were 130.3 mmol/l, 128.0 mmol/l, and 129.0 mmol/l.On (b)(6) 2022, the repeat result was 134.6 mmol/l.It is unknown if the initial results for patients 2 and 3 were reported outside of the laboratory.The na electrode lot number and expiration date were requested but not provided.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2022 and was acceptable.The qc data provided showed a downward trend but was acceptable.The field service engineer (fse) found that the sodium electrode was faulty.The customer had already replaced the electrode and repeated the affected samples with acceptable results.An ise check was performed successfully.The service maintenance actions performed by the fse and the customer 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15959760
• Report Number: 1823260-2022-03966
• Device Sequence Number: 12156079
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• 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): N
• 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): 02/02/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: I400+
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/02/2023
• 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 Sex: Unknown