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

Catalog Number	08464537001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from an unspecified number of patient samples tested on the cobas pro ise analytical unit.The reporter was able to provide one example of a discrepant result.The reporter noted that the initial result did not match the patient's historical runs and referred it to the doctor who agreed to rerun the patient sample.The patient sample was rerun on their other cobas pro ise analytical unit.The initial result from the analyzer was 135 mmol/l.The repeat result from the other analyzer was 126 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
The electrode lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the analyzer and determined the event was caused by a clogged sipper probe.He then replaced the sipper probe and vacuum nozzle; decontaminated the ion-selective electrode (ise) flow path; and replaced the reagents.He performed a 20-cup precision check with successful results.The customer performed calibrations and qcs with successful results.After service, no further issues were reported by the customer.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
• MDR Report Key: 18454397
• Report Number: 1823260-2024-00043
• Device Sequence Number: 16916042
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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): 01/05/2024

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: 12/16/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male