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

Catalog Number	21029371001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable ise results for 3 patients' plasma samples tested on a cobas integra 400 plus analyzer.Results for the sodium (na) test were affected.Sample 1: initial result: 128 mmol/l (accompanied by a data flag).Repeat result: 140 mmol/l.Sample 2: initial result: 117 mmol/l (accompanied by a data flag).Repeat result: 139 mmol/l.Sample 3: initial result: 124 mmol/l (accompanied by a data flag).Repeat result: 138 mmol/l.No questionable results were reported outside the laboratory.The field dispatch for ise calibration errors prompted the repeat of the sample.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The cobas integra 400 plus serial number was (b)(6).The field service engineer (fse) found the ise solution was unstable.He also identified that the onboard na electrode was expired (expiration date of 22-mar-2024) and the wash station had residual water.The liquid level detection (lld) cable set was replaced preventatively on 08-apr-24 but the issue persisted.The fse replaced the na electrode.He then preventatively replaced the ise tubing, the wash station, and the drain valve.Precision studies were performed and they were within specifications.The fse did a performance check and the instrument was performing within specifications.The system resumed the operation without errors.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration was last performed on 09-apr-2024 and was acceptable with no noted alarms.Qc recovery was within the assigned ranges.There was no indication of a performance issue with the reagent.The alarm trace showed no abnormalities.The service action (replacing the na electrode) resolved the issue.No further issues were reported afterward.

• Brand Name: 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: 19241828
• Report Number: 1823260-2024-01349
• Device Sequence Number: 7439751
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 07/05/2024

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: 03/22/2024
• Device Catalogue Number: 21029371001
• Device Lot Number: 31232447
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/05/2024
• 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