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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX
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RADIOMETER MEDICAL APS ABL800 FLEX Back to Search Results
Model Number 393-800
Device Problem Low Test Results (2458)
Patient Problem Hyperbilirubinemia (1903)
Event Date 01/23/2018
Event Type  Injury  
Event Description
The following is stated in the complaint: "the patient is a premature baby and they are measuring on the baby from (b)(6).And everything looks fine.But on (b)(6), the doctors reflects upon a significant lower abl result than from cobas (100 micromol/l) and they where in doubt how to treat the child.The lab finds a plasma sample, which was run on cobas and runs this sample on abl and then the abl gives the same result as the cobas." the patient was diagnosed with prematurity and hyperbilirubinemia.It is stated in the complaint, that treatment of the patient was intensified because of the higher bilirubin results from cobas and that the patient had a significant amount of extra blood drawn, due to the false low results on abl.
 
Manufacturer Narrative
Interference in the sample.It is not possible to determine the type of interference that is caused by the deviation.
 
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Brand Name
ABL800 FLEX
Type of Device
ABL800 FLEX
Manufacturer (Section D)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA  2700
MDR Report Key7291941
MDR Text Key100777259
Report Number3002807968-2018-00011
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K041874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-800
Device Catalogue Number393-800
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 DA
Patient Weight1
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