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

Catalog Number 03003523001

Device Problem Output Problem (3005)

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

Event Date 02/02/2024

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 poorly fitting sealing ring on the reference electrode, causing air to enter.The electrode had recently been replaced.The sealing rings were cleaned and checked for integrity; they were in acceptable condition.The cl electrode was changed.Diagnostic tests were acceptable.Maintenance was performed on the ise module.Calibration and controls were run and expected values were measured.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the chloride electrode on a cobas integra 400 plus.No questionable results were reported outside of the laboratory.The sample resulted in a cl value of 120 mmol/l when tested on the integra 400 plus analyzer.The sample was repeated on an unknown gasometer instrument, resulting in a cl value of 109 mmol/l.This value was considered to be correct by the customer.

Manufacturer Narrative

The investigation determined the service actions resolved the issue.

• Brand Name: CHLORIDE ELECTRODE
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• 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: 18720798
• MDR Text Key: 336618791
• Report Number: 1823260-2024-00460
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03003523001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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