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

Catalog Number	08464537001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number was s6294.The expiration date was not provided.The field service engineer found the ise mixing bowl full of semi-dried serum and the ise probe was bent and was not being washed in the center of the wash station.The customer replaced the probe and the field service engineer checked and adjusted the alignments.He cleaned the ise mixing bowl and ran calibration.Ise precision testing and qc passed.
Event or Problem Description
There was an allegation of questionable high sodium results from the cobas pro ise analytical unit.Patient 1 initial result from another analyzer was 139 mmol/l.The repeat result from the suspect analyzer was 153 mmol/l.Patient 2 initial result from another analyzer was 132 mmol/l.The repeat result from the suspect analyzer was 143 mmol/l.Patient 3 initial result from another analyzer was 129 mmol/l.The repeat result from the suspect analyzer was 135 mmol/l.Patient 4 initial result from another analyzer was 142 mmol/l.The repeat result from the suspect analyzer was 152 mmol/l.The initial results were believed correct.
Additional Manufacturer Narrative
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: 19321540
• Report Number: 1823260-2024-01455
• Device Sequence Number: 20730945
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 06/07/2024

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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1-BRONCHIAL DILATOR
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 136 KG