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

Catalog Number	08464537001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.Calibration, qc, alarm trace, and pre-analytical data were requested but not provided.The field service engineer found that the sonic wash station needed to be cleaned.He cleaned the sonic wash station, replaced the ise probe, and performed all sonic wash adjustments.Precision studies were performed and they were within specifications.The instrument was performing within specifications.The service actions (cleaning the sonic wash station, replacing the ise probe, and performing all sonic wash adjustments) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for an unspecified number of patients' serum/plasma samples tested on a cobas pro ise analytical unit.Results for the sodium (na) test were affected.No discrepant results were provided.The reporter alleged that the difference between the initial and the repeat measurements was >7 mmol/l.The reporter also stated that they had seen a salt build-up on the ultrasonic mixer and for that reason, the samples were re-tested.The repeat results were deemed to be correct.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: 18719775
• Report Number: 1823260-2024-00455
• Device Sequence Number: 7231128
• Product Code: JJE
• UDI-Device Identifier: 07613336158876
• UDI-Public: 07613336158876
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/16/2024

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: 01/28/2024
• Initial Report FDA Received Date: 02/16/2024
• 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: Unknown