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

Catalog Number	10825468001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was not able to determine a specific root cause.The issue appeared to be resolved after the service actions.The calibration data was acceptable and the qc recovery was within the provided ranges prior to the event.The analyzer alarm trace contained abnormal sample aspiration and sample short errors.These are indicators of possible poor sample quality.
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The field service engineer was unable to determine a root cause.He checked and adjusted the sample probe and ise probe, performed mechanism checks, and checked and adjusted the rinse water levels.He found the end squeegee was splashing water intermittently and adjusted it.He removed and cleaned the shields over the reaction disk.He performed ise checks and precision testing which passed within specifications.The customer performed calibration and qc with results within the customer-defined ranges.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable sodium results from the cobas 6000 c 501 analyzer.The initial result was 163 mmol/l and the repeat result was 139 mmol/l.The repeat result was believed 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: 20362860
• Report Number: 1823260-2024-02873
• Device Sequence Number: 15884986
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 10/15/2024

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: 03/16/2025
• Device Catalogue Number: 10825468001
• Device Lot Number: W48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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