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

Catalog Number	08464537001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number was r58 with an expiration date of (b)(6) 2024.The field service engineer did not find a cause for the issue.He flushed the sample probe, vacuum nozzle, and sipper nozzle.He cleaned the ise waste valve, electrode block, and vacuum vessel.He performed precision testing that passed and the customer performed calibration and qc that passed.The investigation did not identify a product problem.The cause of the event could not be determined but appeared to be resolved after the service actions.
Event or Problem Description
There was an allegation of questionable ise indirect gen 2 sodium results from the cobas pro ise analytical unit.One example was provided.The initial result was 150 mmol/l and was reported outside of the laboratory.The repeat result on another cobas pro ise analytical unit was 140 mmol/l.The repeat results were believed 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: 18562522
• Report Number: 1823260-2024-00200
• Device Sequence Number: 12793084
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 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): 01/23/2024

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: 01/13/2024
• Initial Report FDA Received Date: 01/23/2024
• 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