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	02/01/2024
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.Sample 1 initial sodium result was 154 mmol/l and the repeat result was 139 mmol/l.The initial chloride result was 117 mmol/l and the repeat chloride result was 106 mmol/l.Sample 2 initial sodium result was 149 mmol/l and the repeat result was 139 mmol/l.Sample 3 initial sodium result was 149 mmol/l and the repeat result was 139 mmol/l.The repeat results were believed correct.
Additional Manufacturer Narrative
The cobas pro ise analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer found the sipper probe was occulted.He cleaned the sipper probe and preventatively replaced the sample probe and seals.He performed operational and mechanical checks which passed.The customer performed and accepted qc.The investigation determined the service actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 18738230
• Report Number: 1823260-2024-00484
• Device Sequence Number: 19964807
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 02/23/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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