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

Catalog Number	10825468001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable sodium results from the cobas pro ise analytical unit.Sample 111761155 initial result was 149 mmol/l and the repeat result was 140 mmol/l.Sample 111761293 initial result was 140 mmol/l and the repeat result was 134 mmol/l.Sample 111761354 initial result was 138 mmol/l and the repeat result was 132 mmol/l.
Additional Manufacturer Narrative
The cobas pro ise analytical unit serial number was(b)(6).The customer performed quarterly maintenance and has not had any further issues.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer found the fluidic pathways were compromised.He requested the customer to complete monthly maintenance.A precision check was performed with passing results.As the qc recovery was acceptable there was no indication of a performance issue of reagent.The analyzer alarm trace contained sample probe, sample short, and sample probe abnormal aspiration alarms.This is an indication of possible poor sample quality.The investigation determined the service and customer actions resolved the issue.

• Brand Name: NA 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: 19381041
• Report Number: 1823260-2024-01537
• Device Sequence Number: 15375793
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 07/02/2024

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 Expiration Date: 02/15/2025
• Device Catalogue Number: 10825468001
• Device Lot Number: V58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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 Sex: Unknown