MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05641489001

Device Problem Low Test Results (2458)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The ca reagent lot number and expiration date were not provided.When the customer noticed the issue they attempted to recalibrate and calibrations failed.The customer stated qc was within range before the event.The field service engineer (fse) found an issue with a 3-way valve.The fse replaced the 3-way vacuum valve and verified the instrument by performing precision testing and qc.The service actions resolved the issue.

Event Description

The initial reporter questioned low results for approximately 30 patient samples and multiple assays on a cobas 8000 c 701 module.Discrepant results were provided for 1 patient sample tested for calcium (ca).The initial result was 5.5 mg/dl.The repeat result from a different c 701 module was 9.5 mg/dl.The customer stated the questionable results for 1-2 patient samples may have been reported outside of the laboratory and corrected.The customer was not able to provide any clarifications on which patient samples were reported outside of the laboratory.The samples were repeated due to critical low results or delta checks.

• Brand Name: COBAS 8000 C 701 MODULE
• 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: 18787692
• MDR Text Key: 336314543
• Report Number: 1823260-2024-00554
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• 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