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); High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.The na electrode was changed on (b)(6) 2024.The customer uses a 3rd party qc.The customer noted a difference in the qc results from (b)(6) 2024 to (b)(6) 2024 and the issue started on (b)(6) 2024.The field service engineer (fse) found fibers from the gauze pad in the dilution vessel, and the sipper nozzle was not tightened down.He cleaned the dilution vessel, replaced the sample probe, and tightened the sipper nozzle.Precision studies were performed and they were within specifications.The service actions (cleaning the dilution vessel, replacing the sample probe, and tightening the sipper nozzle) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 4 patients' samples tested on a cobas pro ise (cobas pro 3) analytical unit when compared to a different cobas pro ise (cobas pro 2) analytical unit.Results for the sodium (na) test were affected.Sample 1 (patient 1): initial result: 149.9 mmol/l.Repeat result: 141.0 mmol/l (tested on cobas pro 2).Sample 2 (patient 2): initial result: 147.6 mmol/l.Repeat result: 138.5 mmol/l (tested on cobas pro 2).Sample 3 (patient 3): initial result: 148.3 mmol/l.Repeat result: 140.7 mmol/l (tested on cobas pro 2).Sample 4 (patient 4): initial result: 150.0 mmol/l.Repeat result: 144.8 mmol/l (tested on cobas pro 2).Due to previous na issues on the instrument, the samples were repeated.Reportedly, an amended report with the correct results was issued.

• 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: 18766757
• Report Number: 1823260-2024-00527
• Device Sequence Number: 7701323
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 02/23/2024

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: 01/31/2024
• Initial Report FDA Received Date: 02/23/2024
• 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 Age: 73 YR
• Patient Sex: Female