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

Catalog Number	10825468001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).Calibration was last performed on the day of the event.The qc recovery data provided was acceptable.The alarm trace did not contain a conspicuous event.The field service engineer (fse) replaced the na electrode and inspected all other electrodes and cable connections.The fse performed a reagent prime, ise checks, and a 21 cup precision check successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for 4 patient samples on a cobas 6000 c (501) module.The customer was prompted to repeat the samples as qc performed after the initial patient sample run was out of the acceptable range.For sample 1, the initial result was 132 mmol/l.The repeat result was 138 mmol/l.For sample 2, the initial result was 132 mmol/l.The repeat result was 139 mmol/l.For sample 3, the initial result was 131 mmol/l.The repeat result was 138 mmol/l.For sample 4, the initial result was 131 mmol/l.The repeat result was 137 mmol/l.The repeat results were deemed correct.The customer also repeated the samples on another analyzer and the results matched the repeat results.

• 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: 19749838
• Report Number: 1823260-2024-02042
• Device Sequence Number: 12414064
• Product Code: JGS
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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 Expiration Date: 01/12/2025
• Device Catalogue Number: 10825468001
• Device Lot Number: U2011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/16/2024
• 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