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

Catalog Number 03003523001

Device Problem High Test Results (2457)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined the issue was caused by a defective chloride electrode.The analyzer was checked.The electrode was replaced by the customer and the issue was resolved.

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 (serial number (b)(4)).The sample initially resulted in a chloride value of 142 mmol/l and this value was reported outside of the laboratory.The sample was repeated, resulting in a value of 115 mmol/l.The repeat value was deemed correct and a corrected report was issued.

Manufacturer Narrative

Upon customer inspection of the affected electrode, the customer stated they saw something inside the electrode that looked like fungus.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14600728
• MDR Text Key: 301173231
• Report Number: 1823260-2022-01605
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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: 21520466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1