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 02/28/2024

Event Type  malfunction  

Event Description

We received an allegation of questionable ise results for 1 patient sample tested on a cobas pro ise analytical unit when compared to a different cobas pro ise analytical unit.Results for the sodium (na) test were affected.Initial result: 127 mmol/l.This result was questioned by the neonatal intensive care unit and the sample was then repeated.Repeat result: 134.4 mmol/l.The repeat result was deemed to be correct.

Manufacturer Narrative

The na electrode lot number and expiration date were not provided.The field service engineer (fse) found that the sub-optimal calibration yielded low results on the qc and the patient testing.He compared the qc and the calibration data to another analyzer.The fse recalibrated with the fresh calibration solution, performed ise checks and qc and they were all acceptable.He reran patient samples and the results were within an acceptable range generated by the other analyzer.The customer performed calibration and qc and the results were closely correlated with results generated by the other analyzer.The service actions (recalibrating with the fresh calibration solution) resolved the issue.No further issues were reported afterward.

• 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: 18963806
• MDR Text Key: 338447058
• Report Number: 1823260-2024-00876
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• Date Manufacturer Received: 02/28/2024
• 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