MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number 08464537001

Device Problem Low Test Results (2458)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable gen.2 ise indirect for na results for 1 lithium heparin patient sample on a cobas pro ise analytical unit.The initial na result was 126 mmol/l with flag.The doctor questioned the low result and the sample was repeated.The repeat result was 132 mmol/l.The repeat result was deemed correct.

Manufacturer Narrative

The na electrode lot number is t8859 and the expiration date is 30-dec-2024.Calibration was last performed on the day of the event.The qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The field service engineer (fse) found that the mixing vessel, dispense nozzles, vacuum nozzle, and sipper nozzle were all significantly dirty.The fse cleaned all nozzles and mixing vessels, conditioned the electrodes and tubing, and completed an ise check successfully.Calibration, qc, and precision testing were performed successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19051104
• MDR Text Key: 340237683
• Report Number: 1823260-2024-01049
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191899
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08464537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2024
• Initial Date FDA Received: 04/05/2024
• 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