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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER
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RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER Back to Search Results
Model Number 393-092
Device Problem Low Readings (2460)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2019
Event Type  malfunction  
Event Description
According to the complaint received, an intensive care unit reported discrepant na+ results on an abl90 flex plus analyzer for multiple patient results measured (b)(6) 2019 despite of approved controls.A number of samples were measured on two abl90 flex analyzers (1 and 2), see the measurements in the table below: (b)(6).Based on the measurements above the abl90 flex analyzer 2 demonstrated increased measurement results compared to comparison measurements performed on the other abl90 flex analyzer 1.All checks performed in this period on both analyzers were ok.The solution pack on the abl90 flex analyzer 2 was consequently replaced, which stabilized the measurements on the abl90 flex analyzer 2 again.The customer complaints that the abl90 flex analyzer 2 provided false high na+ results while the controls were approved.
 
Manufacturer Narrative
The investigation performed concluded that the root cause was most likely an obstacle/obstruction located in front of the na-sensor in the measurement chamber on the affected abl90 flex analyzer.
 
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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
MDR Report Key8349485
MDR Text Key140156987
Report Number3002807968-2019-00007
Device Sequence Number1
Product Code MQM
Combination Product (y/n)N
PMA/PMN Number
K160153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number393-092
Device Catalogue Number393-092
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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