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 04/22/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer found the chloride electrode needed replacement.He checked the ise system and observed no issues, performed an ise performance check and all passed, and replaced the mixing tower.The customer changed the electrode and ran qc with results within the specified ranges.The investigation determined the service actions resolved the issue.H3 other text : na.

Event Description

There was an allegation of questionable ise indirect gen chloride results from cobas integra 400 plus analyzer serial number (b)(6).Sample 1 initial result was 141 mmol/l and was reported outside of the laboratory.The doctor called questioning the result.The repeat result was 109 mmol/l.On (b)(6) 2023, sample 2 initial result was 136 mmol/l and the repeat result was 108.The questionable result for this sample was not reported outside of the laboratory.The repeat results were believed correct.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16896505
• MDR Text Key: 315097475
• Report Number: 1823260-2023-01556
• 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
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: 03003523001
• Device Lot Number: 21530147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• 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