MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problems Mechanical Problem (1384); High Readings (2459)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event is estimated.

Event Description

When the customer measured patient blood sample, the result of na+ was 180 meq/l which was higher than expected value and then qc error and cal error occurred.The expected value was about 140 meq/l.The customer had a suspicious and checked the analyzer, then they noticed that blood leak occurred from reference membrane and the leak stayed around pathway of ph & reference electrode.After that, they cleaned and disinfected the analyzers.Nobody touched the leaked blood without gloves.

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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12486645
• MDR Text Key: 271887559
• Report Number: 3002807968-2021-00038
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043218
• 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: 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?: No
• 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