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

Catalog Number	10825468001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na and cl electrode lot numbers with expiration dates were not provided.
Event or Problem Description
We received an allegation of questionable results for 5 patient samples tested on a cobas pro ise analytical unit.Discrepant results were provided for 1 patient sample tested for cl electrode (cl) and na electrode (na).The initial results were reported outside of the laboratory where the doctor questioned them.The samples were repeated on a different ise analyzer.The initial na result was 154.9 mmol/l.The repeat result was 140.1 mmol/l.The initial cl result was 116.9 mmol/l.The repeat result was 104.1 mmol/l.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The cobas pro analyzer serial number was (b)(6).Calibration was last performed on 18-jul-2024 with acceptable results.Based on the qc data provided, level 3 qc was acceptable before the event.The sample was spun for 5 minutes at 5100 revolutions per minute (rpm).The spin time may be shorter and the spin speed may be faster than recommended.No issues were identified during a review of the alarm trace data.The field service engineer (fse) found an issue with the electrodes.The fse cleaned the sipper and vacuum nozzles and the mixing bowl.Sodium (na) electrode checks remained very low.The fse replaced all of the electrodes and additional instrument checks were acceptable.The service actions resolved the issue.

• 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 46250-0457
• MDR Report Key: 20157924
• Report Number: 1823260-2024-02582
• Device Sequence Number: 4235411
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 10825468001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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