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 06/30/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with the na electrode on a 9180 electrolyte analyzer.The first patient sample also had discrepant results when tested with the k electrode.The user decided to repeat the affected samples since the initial values did not match previous measurements of the patients.The first sample initially resulted in a na value of 152 mmol/l accompanied by a data flag and repeated as 143 mmol/l.This sample initially resulted in a k value of 12.2 mmol/l accompanied by a data flag and repeated as 4.3 mmol/l.The second sample initially resulted in a na value of 154 mmol/l accompanied by a data flag on (b)(6) 2022 and repeated as 143 mmol/l on (b)(6) 2022.The third sample initially resulted in a na value of 124 mmol/l accompanied by a data flag on (b)(6) 2022 and repeated as 140 mmol/l on (b)(6) 2022.The fourth sample initially resulted in a na value of 137 mmol/l on (b)(6) 2022 and repeated as 129 mmol/l accompanied by a data flag on (b)(6) 2022.The na electrode lot number was 21512762 with an install-by date of (b)(6) 2022.The k electrode lot number was 21513747 with an install-by date of (b)(6) 2022.

Manufacturer Narrative

The field service engineer (fse) found condensation and bubbles on the electrodes.The bubbles were removed from the electrodes.Afterward, the fse performed daily maintenance, ran qc, and performed repeatability testing.The na electrode lot number was 21512762 with an install-by date of 04-mar-2022.This electrode was installed on the instrument on 16-nov-2021.The electrode was valid for use until 02-aug-2022.The event occurred on 30-jun-2022.The na electrode was valid at the time of the event.The k electrode lot number was 21513747 with an install-by date of 01-apr-2022.This electrode was installed on the instrument on 16-nov-2021.The electrode was valid for use until 17-may-2022.The event occurred on 30-jun-2022.As such, the k electrode was invalid at the time of the event.The customer used sample tubes with a gel separator.Serum-separated tubes can contain spray-coated silica.Product labeling states: "do not use sampling containers containing silicone." the sample tube used could affect the na results.Calibration and qc were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 15157890
• MDR Text Key: 304962266
• Report Number: 1823260-2022-02276
• 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
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• 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