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

Catalog Number	21029371001
Medical Device Problem Codes	Mechanical Problem (1384); Low Test Results (2458); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise indirect gen 2 sodium results for qc and patient samples from cobas integra 400 plus analyzer serial number 421575.The initial result was 129.9 mmol/l and the repeat result was 136.2 mmol/l.The questionable result was reported outside of the laboratory and was corrected with the repeat result.
Additional Manufacturer Narrative
The customer replaced the sodium electrode, ise indirect and direct calibrators, and ise solutions.The ise calibration and qc were acceptable.The field service engineer replaced the ise tubing and all three electrodes.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The customer replaced all electrodes, ran precision testing, and ran comparisons on patient samples.Afterward, the customer had no further issues.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16014176
• Report Number: 1823260-2022-04100
• Device Sequence Number: 6561101
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): N
• 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): N
• 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): 03/17/2023

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: 21029371001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/17/2023
• 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