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

Catalog Number	04838084001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode expiration date was not provided.The cobas c111 system serial number was (b)(6).The last maintenance was performed on 21-dec-2022.The na electrode was changed on 05-sep-2023.The customer performed daily maintenance on the c111.He then did probe offset and electrode maintenance.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 9 patients' samples tested with ise sodium (na) assay on a cobas c111 system when compared to a cobas 600 c501 analyzer.Sample 1 (patient 1): 125.3 mmol/l.Rerun result: 137 mmol/l (tested on a different analyzer).Sample 2 (patient 2): 126.2 mmol/l.Rerun result: 140 mmol/l (tested on a different analyzer).Sample 3 (patient 3): 128.1 mmol/l.Rerun result: 135 mmol/l (tested on a different analyzer).Sample 4 (patient 4): 144.3 mmol/l.Rerun result: 158 mmol/l (tested on a different analyzer).Sample 5 (patient 5): 132.1 mmol/l.Rerun result: 139 mmol/l (tested on a different analyzer).Sample 6 (patient 6): 124.7 mmol/l.Rerun result: 132 mmol/l (tested on a different analyzer).Sample 7 (patient 7): 127.8 mmol/l.Rerun result: 144 mmol/l (tested on a different analyzer).Sample 8 (patient 8): 125.6 mmol/l.Rerun result: 136 mmol/l (tested on a different analyzer).Sample 9 (patient 9): 128.9 mmol/l.Rerun result: 136 mmol/l (tested on a different analyzer).The physician questioned the results and asked for the samples to be rerun.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
Inspection of the data showed that on the date of the event and around the time of occurrence, some errors were reported related to sample fill (aspirate sample from the tube) or tube empty messages.The cause was consistent with a sample tube being empty or not having sufficient sample volume.This would indicate a user error of incorrect sample handling.The investigation did not identify a product problem.

• 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: 17994260
• Report Number: 1823260-2023-03404
• Device Sequence Number: 6877216
• Product Code: JGS
• UDI-Device Identifier: 04015630036189
• UDI-Public: 04015630036189
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 04838084001
• 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: 09/29/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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