MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964075001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k electrode lot number was y1252.The electrode expiration date was requested, but not provided.The customer replaced the reagents, primed the system, recalibrated, and ran controls on the first channel.Calibration and controls failed.Quality controls were acceptable prior to the event.The last calibration performed on (b)(6) 2024 was acceptable.The field service engineer found sticking vacuum valves and a chipped dilution vessel.The valves, ultrasonic unit, vacuum nozzles, and dilution nozzles were replaced.Calibration and controls were run; controls were acceptable.Precision studies were performed and were successful.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the k electrode on a cobas 8000 ise module.The customer noticed the patient results did not agree with the patients' history, so they were repeated on the second channel of the analyzer.The repeat results were deemed correct and corrected reports were issued.The first sample initially resulted in a k value of 6.5 mmol/l and it repeated as 4.5 mmol/l.The second sample initially resulted in a k value of 2.5 mmol/l and it repeated as 4.2 mmol/l.

• Brand Name: COBAS 8000 ISE 1800 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: 18704767
• Report Number: 1823260-2024-00440
• Device Sequence Number: 15040503
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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: 05964075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 65 YR
• Patient Sex: Female