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

Catalog Number	21029371001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The other integra 400 plus analyzer serial number was not provided.The customer verbally stated that their qc was acceptable.The field service engineer (fse) found that the onboard calibrators were on for too long and replaced them.The customer performed calibration and qc successfully.The fse stated that the calibrator bottles removed had dates from february and march.Per product labeling, "once opened, ise calibrator direct is stable on-board for up to 8 weeks." the service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.H3 other text : na.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for 1 patient sample on a cobas integra 400 plus module.The initial na result from integra analyzer serial number (b)(6) was 133 mmol/l.The sample was repeated on another integra analyzer was 127 mmol/l.The sample was repeated on a another analyzer due to ongoing ise issues with that analyzer.The initial result of 133 mmol/l was deemed correct.No questionable results were reported outside of the laboratory.

• 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: 17356443
• Report Number: 1823260-2023-02356
• Device Sequence Number: 5152040
• 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
• Report Date (Section B): 07/19/2023

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: 06/20/2023
• Initial Report FDA Received Date: 07/19/2023
• 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 Age: 88 YR
• Patient Sex: Female