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

Catalog Number	05641489001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1823260-2024-00554
• Device Sequence Number: 7757092
• Product Code: JJE
• UDI-Device Identifier: 04015630928255
• UDI-Public: 04015630928255
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 05641489001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown