MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Two separate incidents from the same hospital have been reported related to this instrument (serial no.(b)(4)).Both incidents involves a different patient.The incidents have been assigned the mdr no.'s 3002807968-2018-00002 (this report) and 3002807968-2018-00003.

Event Description

On (b)(6) 2017, a patient had his blood gas done at 13:29 and his blood glucose measured as 1.7 mmol/l on an abl90 flex plus analyzer.This did fit with the clinical picture, so he was given 25mls of 50% dextrose.At 14:12 he had another gas sample taken and his glucose was found to be 2.4 mmol/l.His glucose was also checked on the roche accu-chek inform ii glucose meter at 14:10 and a result of 9.5 mmol/l obtained.The customer was then concerned that the abl90 flex plus analyzer was producing falsely low glucose results.On the calibrations done at 13:20, 13:29, 14:00 and 14:12 glucose had passed.There was another calibration at 14:32 were glucose failed and after this the advice was to replace the sensor which was duly done.

Manufacturer Narrative

After repeated attempts to gain more information from the customer, no response have been received.Since no additional information could be obtained, it was not possible to investigate this case further.The root cause of the incident could then not be identified.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS ANALYZER
• 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: david kawiecki ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7167023
• MDR Text Key: 96833770
• Report Number: 3002807968-2018-00002
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2017
• 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