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

Catalog Number	08464537001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were requested, but not provided.The field service engineer found a dirty sample probe.A wash station was not cleaning the probe properly.A vacuum nozzle was also found dripping into the mixing vessel.The probe, the ise block, and nozzles were cleaned.The vacuum nozzle end was deformed, so it was replaced.The ise flow paths were primed.Calibration, controls, and precision studies were performed; all results met specifications.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the na electrode on a cobas pro ise analytical unit.The sample initially resulted in a na value of 151.3 mmol/l.The doctor questioned the result and the sample was repeated on a second analyzer.The repeat result was 144.8 mmol/l.The repeat value was deemed correct.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• 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: 18796593
• Report Number: 1823260-2024-00575
• Device Sequence Number: 7131515
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191899
• 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): 02/28/2024

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: 08464537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2024
• Initial Report FDA Received Date: 02/28/2024
• 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 Sex: Unknown