MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-801

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 12/17/2017

Event Type  malfunction  

Manufacturer Narrative

Recall number: correction/removal reporting number is yet to be determined.(b)(4) and crr will be submitted no later than july 2nd 2018.

Event Description

According to the complaint, the emergency department at (b)(6) has over two periods (b)(6) 2017.And (b)(6) 2018 experienced low ccrea measurements and low quality controls at level 1 on a abl827 analyzer.The customer state that they have identified apx 1200 individuals during this period with potential risk of measured low ccrea.60% of these individuals were also analyzed for ccrea in the central laboratory.Comparison between these two methods showed that the abl was measuring false low.No individual patient data is available in this case.New information became available on june 1st, 2018, when a health hazard evaluation was initiated.This evaluation concluded, that if the malfunction recurred, it could lead to serious injury, why this case is reported now.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800
• 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: bolette duun-christensen ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 7649794
• MDR Text Key: 112864668
• Report Number: 3002807968-2018-00046
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K051968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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