MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER

Catalog Number 03157334001

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The lithium electrode lot number and expiration date were requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the lithium electrode (li+) on a 9180 electrolyte analyzer.The first sample initially resulted in a lithium value of 0.23 mmol/l and it repeated as 0.29 mmol/l.The sample was repeated on (b)(6) 2024, resulting in a value of 0.69 mmol/l.The second sample initially resulted in a lithium value of 0.53 mmol/l on (b)(6) 2024.The sample was repeated twice on (b)(6) 2024, resulting in lithium values of 1.79 mmol/l and 1.53 mmol/l.

Manufacturer Narrative

It was determined that the lithium electrode was installed on the instrument on 21-oct-2023.The on-board use time for the lithium electrode is 13 weeks.The in use time for the electrode was exceeded.It was also noted that the customer did not perform regular deproteinizing of the instrument.Per product labeling: "incorrect results may lead to errors in diagnosis, posing danger to the patient.Do not use reagents or consumables that have exceeded their expiry date, otherwise you may obtain inaccurate data." the investigation did not identify a product issue.

• Brand Name: 9180 ELECTROLYTE ANALYZER
• Type of Device: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18818742
• MDR Text Key: 336771723
• Report Number: 1823260-2024-00626
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): Y
• Reporter Country Code: JO
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03157334001
• 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