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 02/26/2024

Event Type  malfunction  

Event Description

The initial reporter stated had issues with their ise control recovery on the cobas pro ise analytical unit.The customer cleaned the dilution vessel and ran the controls again; the controls were acceptable.The customer then noted they received delta check warnings for some patient sample results, so they repeated all samples that initially recovered above the reference range.The affected samples were initially tested in the first rack position, so the samples were repeated by placing water in the first rack position and patient samples in the rest of the positions.The customer provided data for three patient samples that had discrepant na electrode results.The first sample initially resulted in a na value of 147 mmol/l and it repeated as 141 mmol/l.The second sample initially resulted in a na value of 147 mmol/l and it repeated as 141 mmol/l.The third sample initially resulted in a na value of 146 mmol/l and it repeated as 139 mmol/l.The repeat results were deemed correct.

Manufacturer Narrative

The serial number of the cobas pro ise analytical unit is (b)(6).The field service engineer could not determine a cause.All valves in the ise flow path were checked and one valve was replaced.The mixing vessel was cleaned and nozzles were replaced.An ise check was performed.The customer ran calibration and controls; the results were within the customer's established ranges.The investigation is ongoing.

Manufacturer Narrative

Calibration was acceptable.Of the provided quality control data, one level of sodium control was outside of range on (b)(6) 2024.The customer noted that controls ran successfully prior to the event.The investigation determined the service actions resolved the issue.

• 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: 18892980
• MDR Text Key: 337569552
• Report Number: 1823260-2024-00743
• 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: K191899
• 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: 03/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: Q49
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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