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

Catalog Number	08464537001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise indirect gen 2 results from the cobas pro ise analytical unit.One example was an initial result of 129 mmol/l and a repeat result of 136 mmol/l.The repeat results were believed correct.
Additional Manufacturer Narrative
The electrode lot number and expiration date were not provided.The field service engineer checked the analyzer and did not determine a cause.He replaced all of the electrodes and performed maintenance.He ran precision testing that was within specifications and the customer performed qc that was within ranges.The analyzer alarm trace did not contain any conspicuous events.The issue appeared to be resolved after the service actions.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: 18702717
• Report Number: 1823260-2024-00432
• Device Sequence Number: 7217040
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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): 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: 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: 02/01/2024
• 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: 58 YR
• Patient Sex: Male