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

Catalog Number	09237216001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise indirect gen 2 sodium results from the cobas 6000 c 501 analyzer.The initial result was 160 mmol/l and the repeat result on the same analyzer was 135 mmol/l.The sample was repeated on an integra 400 analyzer and the result was 134 mmol/l.The repeat result was believed correct.
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d1 brand name and d4 catalog no were updated.The field service engineer checked the analyzer and could not duplicate the issue.The customer ran qc and repeated patient samples.No further discrepancies or errors were found.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ISE SODIUM 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: 18851597
• Report Number: 1823260-2024-00681
• Device Sequence Number: 7214761
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K963627
• 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): 04/03/2024

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: 09237216001
• Device Lot Number: R51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMOXICILLIN; BENEDRYL; PHOSOMAX
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 64 KG