MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX ANALYZER

Model Number 393-090

Device Problem High Readings (2459)

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

Event Date 06/05/2021

Event Type  malfunction  

Event Description

According to the complaint the event happened at 09:23 on (b)(6) 2021.By phone the customer told that the abl90 flex analyzer gave thb = 10 g/dl on the blood sample while blood cell counter.(b)(6).The patient is deceased, but it has been confirmed by the customer that the death was not related to the reported discrepant measurement.

Manufacturer Narrative

Thb measurement is very sensitive to pre-analytical handling.There are no indications in the datalogs or customer communication that the analyzer is systematically discrepant.The observed discrepant is most likely caused by pre-analytical sample handling.

• Brand Name: ABL90 FLEX ANALYZER
• Type of Device: ABL90 FLEX ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12007883
• MDR Text Key: 280475050
• Report Number: 3002807968-2021-00019
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909
• Combination Product (y/n): N
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1