MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX,

Model Number 393-800

Device Problem High Readings (2459)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

According to the customer a sodium measurement result was elevated and not within the clinical expectation.A second sample was drawn, and this also provided an elevated sodium result.A sample was then run on an alternative analyzer where the sample was more in line with the clinical picture.(b)(6).Based on the measurements the customer considered the sodium measurement from the abl800 flex analyzer as false high.No reports of death or serious injury.

Manufacturer Narrative

Correction in sodium measurements received 06sep2021: the informed sodium measurements and the sample no's have been confirmed by the originator, but the order of sodium measurements and sample no's have been corrected in the sample table: sample#: (b)(4) run on (b)(6) 2021 @ 18:03 provided a na result of 174 mmol/l.The operator did not trust this result and drew a second sample from a a-line to rule out sampling errors, sample#: (b)(4) ran on (b)(6) 2021 @ 18:13, provided a result of 170 mmol/l.The sample was then taken to theatres and measured on abl90 flex, 090r0376n005 and the reported sodium result was 136, sample#: (b)(4) ran on the (b)(6) @18:35.Patient (b)(6) icu theatres sample#: (b)(4), sample#: (b)(4), sample#: (b)(4), na+ (mmol/l) 174, 170, 136.

Manufacturer Narrative

Radiometer investigation of the received datalogs indicates a compromised electrical connection between sensors and the reference sensor.The reference membrane was replaced on (b)(6) 2021.Leakage in the reference chamber likely caused the experienced measurement issues.The root cause of the leakage could not be determined.

• 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: anders noerregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12486117
• MDR Text Key: 280901712
• Report Number: 3002807968-2021-00037
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R0479N004
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2008
• 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