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

Catalog Number	04838084001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number and the expiration date were requested but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from an unspecified number of patient samples tested on the cobas c 111 with ise.The reporter stated they have been receiving low na patient results from the analyzer.The reporter was able to provide one patient sample with discrepant results: it is unclear if the initial result was reported outside of the laboratory.The initial result did not match the delta check prompting the rerun of the patient sample.The initial na result from the analyzer was 129 mmol/l.The first repeat result from the siemens dimension analyzer was 140 mmol/l.The second repeat result from the analyzer was 140 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
Medwatch fields a2 date of birth, d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The field service engineer inspected the analyzer and determined the event was caused by the na or ion-selective electrode (ise) tubing.He then replaced this part.The investigation determined the event was caused by the na electrode.The investigation determined the service actions resolved the issue.

• Brand Name: ISE 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 46250-0457
• MDR Report Key: 19212671
• Report Number: 1823260-2024-01313
• Device Sequence Number: 12693934
• Product Code: JGS
• UDI-Device Identifier: 04015630036189
• UDI-Public: 04015630036189
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• 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): 05/22/2024
• 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 Catalogue Number: 04838084001
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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 Age: 47 YR
• Patient Sex: Male