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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX
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RADIOMETER MEDICAL APS ABL90 FLEX Back to Search Results
Model Number 393-090
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2019
Event Type  malfunction  
Event Description
According to the customer, the abl90 flex reported false low results for ica.A sample was measured by the abl90 flex with result for ica of 1.04 mmol/l.Comparison results from an abl800 and a rapidlab 1265 analyzer gave results of 1.23 mmol/l.Fourteen patient test has been affected, however, no reports were received that any patients were maltreated.After the comparison test a calibration was performed and the ica-parameter failed.A manual flush was then performed and subsequently calibration was ok and ica level normalized to same as the abl800 flex.
 
Manufacturer Narrative
The root cause could not be found, however, it is suspected that the incident was caused by a micro clot.
 
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Brand Name
ABL90 FLEX
Type of Device
ABL90 FLEX
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
MDR Report Key9127580
MDR Text Key204369833
Report Number3002807968-2019-00042
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K092686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-090
Device Catalogue Number393-090
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/03/2019
Initial Date FDA Received09/27/2019
Supplement Dates Manufacturer Received11/01/2019
Supplement Dates FDA Received11/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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