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

Catalog Number 10825468001

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the na electrode on a cobas 6000 c 501 analyzer.No questionable results were reported outside of the laboratory.The samples were repeated due to the values being considered critical.The first sample initially resulted in a na value of 232 mmol/l and when repeated on a different analyzer, the result was 140 mmol/l.The second sample initially resulted in a na value of 252 mmol/l and it repeated as 202 mmol/l.When repeated on a different analyzer, the result was 142 mmol/l.The 142 mmol/l value was deemed correct.

Manufacturer Narrative

The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.

Manufacturer Narrative

The field service engineer found a hole in the vacuum tubing, causing cells to overflow.The tubing was replaced and the tubing bundle was adjusted so that it does not rub.The vacuum pump diaphragms were checked, valves were flushed, and mechanism checks were performed.The reagent probe was adjusted and the system was purged of air.A hardware check test and ise checks passed.The customer ran calibration and controls with passing results.Precision studies were performed.The investigation determined the service actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: NA ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18828486
• MDR Text Key: 336888241
• Report Number: 1823260-2024-00643
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10825468001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1