MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Non Reproducible Results (4029)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they had issues with errors indicating no fluid detected at the ise sensor of cobas integra 400 plus.The customer changed the mix tower and other maintenance actions, but the analyzer generated the same alarm.The customer inspected the system and found there was a leak coming from pump tubing in the ise module.There was also salt buildup in the middle of the tubing.The customer changed the tubing and tightened a screw that was loose.The customer primed and initialized the system and these were completed without issue.There was no further leaking.The customer ran calibration and controls.Controls were acceptable and there were no alarms.The customer started processing samples and one patient sample had discrepant results for the following tests: na+ electrode, k+ electrode, and chloride electrode.No incorrect results were reported outside of the laboratory.The customer also received another alarm indicating the ise sensor does not detect fluid.The sample initially resulted in a na value of 174 mmol/l, which repeated as 159 mmol/l.The sample initially resulted in a k value of 5.5 mmol/l, which repeated as 5.0 mmol/l.The sample initially resulted in a cl value of 119 mmol/l, which repeated as 140 mmol/l.The customer did not know which results were correct.The na electrode lot number was 21504347, with an expiration date of 30-jul-2021.The k electrode lot number was 21504548, with an expiration date of 13-aug-2021.The cl electrode lot number was 21511560, with an expiration date of 01-oct-2021.

Manufacturer Narrative

Quality controls were within range, showing no indication of a reagent performance issue.The field service engineer determined there was an issue with ise tubing.The ise module tubing was replaced.An ise performance check was performed and the ise was initialized.Calibration and controls were successful.Precision studies were successful.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS INTEGRA 400 PLUS
• Type of Device: CLINICAL CHEMISTRY 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12632074
• MDR Text Key: 279307599
• Report Number: 1823260-2021-02989
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: 03245233001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Female