MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problems High Readings (2459); Output Problem (3005)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

According to the complaint on (b)(6) 2021 the customer noticed false high measurements of sodium on five patients on a abl800 flex analyzer.The customer noticed that the refence membrane was full of blood and chamber was flooded with blood and leaked into ph electrode chamber.She cleaned up the blood and replaced the membrane, ran calibrations and qc, these passed and the patients after that were good.The qc and calibrations passed in the morning, showing no indication of a problem on the analyzer.The below are the false high measurements of na+.Comparison measurement/expected value is 140mmol/l.Patient 1: 159 mmol/l.Patient 2: 170 mmol/l.Patient 3: 161mmol/l.Patient 4: 157mmol/l.Patient 5: 159mmol/l.No reports of death or serious injury.

Event Description

According to the complaint on (b)(6) 2021 the customer noticed false high measurements of sodium on five patients on a abl800 flex analyzer.The customer noticed that the refence membrane was full of blood and chamber was flooded with blood and leaked into ph electrode chamber.She cleaned up the blood and replaced the membrane, ran calibrations and qc, these passed and the patients after that were good.The qc and calibrations passed in the morning, showing no indication of a problem on the analyzer.The below are the false high measurements of na+.Comparison measurement/expected value is 140mmol/l.Patient 1: 159 mmol/l.Patient 2: 170 mmol/l.Patient 3: 161mmol/l.Patient 4: 157mmol/l.Patient 5: 159mmol/l.No reports of death or serious injury.

Manufacturer Narrative

The radiometer investigation has shown that it is plausible that the leakage on the reference membrane is the root cause for the deviating measurement performance on sodium.The investigation is ongoing.

Manufacturer Narrative

The radiometer investigation is finalized and the root cause is concluded to be "supplied materials outside specification".

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: ditte kroeyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13009643
• MDR Text Key: 285739569
• Report Number: 3002807968-2021-00064
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1340N002
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1