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

Catalog Number 03003523001

Device Problem Low Test Results (2458)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) performed periodic maintenance, including checking, cleaning, and lubricating all mechanisms.The customer performed calibration and qc successfully.The investigation is ongoing.

Event Description

There was an allegation of questionable gen.2 ise indirect for cl results for 1 patient sample on a cobas integra 400 plus.The initial cl aliquot result was 88 mmol/l.As the result was low, this prompted the customer to rerun qc.The qc was out of range and the customer performed troubleshooting to get the qc within range.When qc was back within range, the customer repeated the patient sample aliquot and the repeat result was 101 mmol/l.No questionable results were reported outside of the laboratory.The repeat result was deemed correct.The analyzer serial number is (b)(6).

Manufacturer Narrative

The qc recovery data provided was acceptable.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 17063826
• MDR Text Key: 316773829
• Report Number: 1823260-2023-01858
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• 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: 07/10/2023
• 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
• Treatment: AMLODIPINE; VALSARTAN
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 83 KG