MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 ELECTROLYTE ANALYZER

Model Number ISE 9180

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for sodium (na) on a electrolyte analyzer ise 9180 instrument.The initial result was 126 mmol/l.The sample was repeated twice with results of 160 mmol/l and 140 mmol/l.Based on the patient's previous results, the result of 140 mmol/l was believed to be correct.No questionable results were reported outside of the laboratory.The na electrode lot number and expiration date were not provided.The electrode was last replaced in (b)(6) 2018.

Manufacturer Narrative

The na electrode lot number was 21573347 and was installed prior to 13-apr-2018.Based on the installation date, this electrode should have been replaced in sep-2018.The reference electrode was installed in 2009.Based on the installation date, this electrode should have been replaced on 30-jun-2010.A new na electrode (lot number 21594147) and a new reference electrode were installed on 31-jan-2020.Since replacing the electrodes, the customer has had no further issues.The customer used non-roche qcs.Product labeling states: "use of non-approved consumables may null and void the warranty.Use of consumables that were not produced by roche, including but not limited to electrodes, calibration and cleaning solutions, qc-material and related accessories, may result in malfunction of the analyzer and may render the warranty null and void.Roche offers an aqueous qc material that should be used to ensure that the 9180 electrolyte analyzer provides measurements of high quality in order to protect patients." there was no preventive maintenance contract with a roche distributor.It is not known if recommended maintenance procedures were performed.Product labeling states: "you should replace the main tubing harness at least once a year.All other annual maintenance actions have to be performed by roche service representatives.To avoid potential malfunctions to the analyzer, schedule your yearly maintenance promptly." the customer stated the current cleaning solution was expired.Product labeling states: "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 problem.The specific cause of the event could not be determined.

• Brand Name: ROCHE 9180 ELECTROLYTE ANALYZER
• Type of Device: ELECTROLYTE ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9710864
• MDR Text Key: 197995840
• Report Number: 1823260-2020-00440
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• PMA/PMN Number: K961458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISE 9180
• Device Catalogue Number: 03157334001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1