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

Catalog Number	21029371001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from three patient samples tested on the cobas integra 400 plus.The initial results were not reported outside of the laboratory.The patient samples were rerun on their other analyzer.Sample 1: the initial result was from the analyzer 168.2 mmol/l.The repeat result from the other analyzer was 139.0 mmol/l.Sample 2: the initial result from the analyzer was 174.8 mmol/l.The repeat result from the other analyzer was 139.0 mmol/l.Sample 3: the initial result from the analyzer was 158.8 mmol/l.The repeat result from the other analyzer was 139.0 mmol/l.
Additional Manufacturer Narrative
The serial number of the cobas integra 400 plus is (b)(6).The customer recalibrated the ion-selective electrode (ise) module.The results showed instability.They then cleaned the mixing tower; and replaced the ise rack reagents, direct calibrator, and probe.They also checked and activated the electrodes; and conditioned the ise tubing.The customer recalibrated with successful results.The investigation did not identify a product problem.The cause of the event could not be determined. .

• 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: 17625727
• Report Number: 1823260-2023-02772
• Device Sequence Number: 6202062
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 08/25/2023

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): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/25/2023
• 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