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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 High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
The case is currently under investigation.A possible root cause could be sample handling, where hemolysis occurred and triggered elevated values for potassium.However, this has still not been conclusively been confirmed yet.
 
Event Description
When the customer measured patient sample, potassium blood concentration was higher than expected: 14.9meq/l.Therefore, the sample was remeasured on this analyzer, obtaining a value of 4.5meq/l.In addition, a sample was sent to the central lab and confirmed the fact that first measurement can be reported as false high.Throughout this event, there was no patient diagnostic impact and no health hazard.Abl90 flex plus: 09:44 14.9meq/l(higher than expected), 09:52 4.5meq/l(expected).Central lab: 10:00 4.5meq/l(expected).
 
Manufacturer Narrative
The product code in field d2 and the udi number in field in d4 have been updated and corrected in this report.It was concluded that hemolysis of the sample was a likely root cause.
 
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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 Key8801559
MDR Text Key207738821
Report Number3002807968-2019-00034
Device Sequence Number1
Product Code MQM
UDI-Device Identifier05700693930923
UDI-Public(01)05700693930923
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 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-092
Device Catalogue Number393-092
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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