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	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was asked when a sample probe was last changed and when checking the software, it showed (b)(4).The customer replaced the probe and then repeated the complained sample.The sample na result after the probe change was 133 mmol/l.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the na+ electrode on a cobas integra 400 plus (serial number (b)(4)).The sample initially resulted in a na value of 130 mmol/l and repeated as 131 mmol/l on the integra 400 plus analyzer.The initial value was reported outside of the laboratory and questioned by a doctor.The sample was sent to another facility and tested on an unknown analyzer, resulting in a value of 137 mmol/l.The repeat value of 137 mmol/l was deemed correct.
Additional Manufacturer Narrative
Quality control recovery was acceptable.The field service engineer found no issues with the analyzer.Precision studies and quality control checks were executed successfully and data was within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 16566976
• Report Number: 1823260-2023-00866
• Device Sequence Number: 20307160
• 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): 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): 04/10/2023

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 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: 02/28/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "HCT2"/"HCTZ"; ATORVASTATIN; IRBESARTAN
• Patient Age: 63 YR
• Patient Sex: Male