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 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

The qc recovery data provided was acceptable.The field service engineer (fse) replaced the cl electrode and performed a 21-cup precision test successfully.The customer performed calibration and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

Event Description

There was an allegation of questionable gen.2 ise indirect for cl results for 3 patient samples on a cobas integra 400 plus.The customer was prompted to repeat the samples as their afternoon qc was out of range, the results did not meet their clinical pictures, and they questioned the high results.On (b)(6) 2023, sample id (b)(6) had an initial cl result of 146 mmol/l.The repeat result was 104 mmol/l.On (b)(6) 2023, sample id (b)(6) had an initial cl result of 185 mmol/l.The repeat result was 107 mmol/l.On (b)(6), sample id (b)(6) had an initial cl result of 139 mmol/l.The repeat result was 104 mmol/l.No questionable results were reported outside of the laboratory.The repeat results were deemed 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17627079
• MDR Text Key: 322318694
• Report Number: 1823260-2023-02781
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215015353
• UDI-Public: 08430215015353
• Combination Product (y/n): Y
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03003523001
• Device Lot Number: 21525147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/25/2023
• 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
• Patient Age: 37 YR
• Patient Sex: Male