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

Catalog Number 03246353001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable gen.2 ise indirect for na and cl results for 3 patients on a cobas pro ise analytical unit and an abl827 analyzer.This medwatch will cover chloride.Refer to medwatch with a1 patient identifier pt (b)(6) for information on the sodium results.The doctor questioned the patient results as they did not match the patients' previous results.The provided results are from separate samples.On (b)(6) 2024, patient 1 had a serum na result of 153 mmol/l and a cl result of 113 mmol/l.The patient had a whole blood sample collected and run on an abl827 analyzer and the na result was 145 mmol/l.On (b)(6) 2024, the patient had sample collected and the serum na result of 152 mmol/l and a cl result of 116 mmol/l.The patient had another serum sample collected and the na result was 143 mmol/l and a cl result of 107 mmol/l.On (b)(6)2024, patient 2 had a serum na result of 151 mmol/l and a cl result of 111 mmol/l.The patient had a whole blood sample collected and run on an abl827 analyzer and the na result was 142 mmol/l.On (b)(6) 2024, patient 3 had a serum na result of 151 mmol/l and a cl result of 112 mmol/l.The patient had a whole blood sample collected and run on an abl827 analyzer and the na result was 140 mmol/l.On (b)(6) 2024, the patient had another sample collected and the serum na result was 149 mmol/l and a cl result of 112 mmol/l.

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.The field service engineer (fse) found that the ise fluidics line was contaminated.The fse cleaned the ise fluidics line and bowl with bleach and replaced the electrodes.A precision test, calibration, and qc were performed successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: CL ELECTRODE
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19084672
• MDR Text Key: 339985921
• Report Number: 1823260-2024-01096
• Device Sequence Number: 1
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191899
• 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: 05/21/2024
• 2 Devices were Involved in the Event: 1 2

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: 03246353001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/21/2024
• 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
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 129 KG