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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 Problems Mechanical Problem (1384); High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
When the customer measured a patient blood sample on the abl800, the result of na+ was 175 meq/l which was higher than the expected value of 140 meq/l.The customer checked the analyzer and noticed that blood leak occurred from reference membrane.Nobody touched the leaked blood without gloves.
 
Manufacturer Narrative
The radiometer investigation is finalized and the root cause is concluded to be 'supplied materials outside specification.'.
 
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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
Manufacturer (Section G)
RADIOMETER MEDICAL APS
aakandevej 21
broenshoej, 2700
DA   2700
Manufacturer Contact
tom engdahl
aakandevej 21
broenshoej, 2700
DA   2700
MDR Report Key12486644
MDR Text Key271886885
Report Number3002807968-2021-00039
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043218
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number393-800
Device Catalogue Number393-800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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