MAUDE Adverse Event Report: ROCHE DIAGNOSTICS 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem High Test Results (2457)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the sodium electrode on a 9180 electrolyte analyzer.The sample initially resulted in a sodium value of 154 mmol/l and repeated as 139 mmol/l.No questionable result was reported outside of the laboratory.The lot number of the sodium electrode was 21520747, with an expiration date of 14-oct-2022.

Manufacturer Narrative

The na electrode lot 21520747 had an install date before 14-oct-2022.The k electrode lot was 21520766 with an install date before 02-sep-2022.The electrodes were valid on 12-sept-2022.The electrodes could not be provided for investigation.According to the customer, the instrument worked acceptably until 12-sep-2022.No information was provided if the quality controls were acceptable on the day of the event.Based on pictures of the affected electrodes, there was enough internal fluid in na and ref electrodes.There was no visible corrosion or defect on the electrodes, or in the measurement chamber.Further investigation did not confirm the suspected sample contamination by the gel of one of the sample tubes used by the customer.Ise 9180 instrument sn (b)(6) passed quality control testing and was within specification at the time of production.No irregularities occurred during the time of production of na electrode lot 21520747 and k electrode lot 21520766.The issue did not reoccur after performing cleaning/washes.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

A second patient sample had discrepant sodium and potassium electrode results when tested on the 9180.No incorrect results were reported outside of the laboratory.On (b)(6) 2022, the customer ran controls and these were outside of range.The customer decided to run patient samples anyways and the second patient sample initially resulted in a sodium value of 126 mmol/l.The sample was repeated, resulting in a sodium value of 151 mmol/l.The sample was repeated again, resulting in a sodium value of 167 mmol/l and a potassium value of 3.7 mmol/l.The customer was advised to clean sodium and potassium electrodes with deproteinizer, perform maintenance, and run calibration.The customer repeated controls and values improved.The second sample was repeated again, resulting in a sodium value of 131 mmol/l and a potassium value of 5.6 mmol/l.The second patient sample resulted in a ca value of 1.26 mmol/l.

• 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; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15608164
• MDR Text Key: 304182767
• Report Number: 1823260-2022-03168
• Device Sequence Number: 1
• Product Code: JFP
• UDI-Device Identifier: 04015630031832
• UDI-Public: 04015630031832
• Combination Product (y/n): N
• Reporter Country Code: NU
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1