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 and 3002807968-2018-00003 (this report).

Event Description

On (b)(6), a patient had his blood gas measured on an abl90 flex plus analyzer and a result of 1.2 mmol/l was obtained.As this did not fit the clinical picture no treatment was given.Again at 14:00 another glucose reading of 1.6 mmol/l was obtained.At 14:04 on the roche glucose meter a glucose level of 6.1 mmol/l was obtained.The customer was then concerned that the abl90 flex plus analyzer was producing falsely low glucose results.When the nurse logged into aqure to check the itu gas analyser at 14:20 all the parameters were green and there were no errors.Unfortunately during these times no glucose samples were sent to the lab to check the 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: 7167037
• MDR Text Key: 96598643
• Report Number: 3002807968-2018-00003
• 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