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

Catalog Number 21029371001

Device Problems Mechanical Problem (1384); Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the integra 400 plus analyzer is (b)(6).The field service engineer determined there was a potential issue with the mixing tower seals.The mixing tower seals were replaced and ise tubing was adjusted.An ise performance check, calibration, control, and precision studies were performed.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the sodium electrode on a cobas integra 400 plus analyzer.The customer noted they have been receiving frequent errors on the instrument after tubing had been replaced on the analyzer the week before.The sample initially resulted in a na value of 124 mmol/l.The doctor questioned the value, so the sample was repeated.The repeat na value was 135 mmol/l.The repeat value was deemed correct.

Manufacturer Narrative

Medwatch fields d1-d4, g1, and g4 were updated.The investigation determined the service actions resolved the issue.

• Brand Name: SODIUM ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18995945
• MDR Text Key: 338887947
• Report Number: 1823260-2024-00931
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 04015630032457
• UDI-Public: 04015630032457
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21029371001
• Device Lot Number: 215303547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN (TYLENOL EXTRA STRENGTH EZ TABLET); APIXABAN TABLET; FENTANYL TRANSDERMAL FILM; LEVOTHYROXINE TABLET; LORATADINE TABLET; LORAZEPAM TABLET; NALOXONE NASAL SPRAY; ODANSETRON TABLET; OMEPRAZOLE CAPSULE; OXYCODONE TABLET; PROCHLORPERAZINE TABLET; TRIAMCINOLONE TOPICAL CREAM
• Patient Age: 53 YR
• Patient Sex: Male