MAUDE Adverse Event Report: ROCHE DIAGNOSTICS NA ELECTRODE; ELECTRODE, ION SPECIFIC, SODIUM

Catalog Number	10825468001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pro ise analytical unit serial number was (b)(6).The calibration was last performed on 17-apr-2024 and it was acceptable.The qc was within the assigned ranges.There was no indication of a performance issue with the reagent.The alarm trace showed a couple of sample probe: abnormal aspiration alarms.The field service engineer found that ise fluidic lines were dirty.He replaced the preventive maintenance kit parts and cleaned ise fluidic lines.He then did operational and mechanical checks and the instrument performed within specifications.The root cause was due to dirty ise fluidic lines.The service actions (cleaning ise fluidic lines) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient plasma sample tested on a cobas pro ise analytical unit compared to a different cobas pro ise analytical unit.Results for the sodium (na) test were affected.Initial result: 150 mmol/l.The physician questioned the result and the samp,e was repeated.Repeat result: 142 mmol/l (tested on another cobas pro ise).The repeat result was deemed to be correct.

• Brand Name: NA ELECTRODE
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19260757
• Report Number: 1823260-2024-01376
• Device Sequence Number: 19484842
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 05/07/2024

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 Expiration Date: 12/24/2024
• Device Catalogue Number: 10825468001
• Device Lot Number: T73
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/07/2024
• 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
• Patient Sex: Unknown