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	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for 10 patient samples on a cobas e 411 immunoassay analyzer.The customer was having calibration issues with the na electrode and replaced it before repeating the samples.For patient 1, the initial na result was 134 mmol/l.The repeat result was 139.28 mmol/l.For patient 2, the initial na result was 133 mmol/l.The repeat result was 141 mmol/l.For patient 3, the initial na result was 120 mmol/l.The repeat result was 135 mmol/l.For patient 4, the initial na result was 130 mmol/l.The repeat result was 136 mmol/l.For patient 5, the initial na result was 133 mmol/l.The repeat result was 140 mmol/l.For patient 6, the initial na result was 134 mmol/l.The repeat result was 141 mmol/l.For patient 7, the initial na result was 135 mmol/l.The repeat result was 143 mmol/l.For patient 8, the initial na result was 134 mmol/l.The repeat result was 141 mmol/l.For patient 9, the initial na result was 133 mmol/l.The repeat result was 141 mmol/l.For patient 10, the initial na result was 134 mmol/l.The repeat result was 140 mmol/l.No questionable results were reported outside of the laboratory.The repeat results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) replaced the ise pump head, checked tubing, and performed calibration and qc successfully.The service maintenance actions performed by the fse 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: 17335329
• Report Number: 1823260-2023-02273
• Device Sequence Number: 6477287
• 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
• Report Date (Section B): 07/17/2023

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: 05/12/2023
• 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: 06/20/2023
• Initial Report FDA Received Date: 07/17/2023
• 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