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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 High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
According to the complaint, the customer reported about deviation on k during blood sample measurement on an abl800 on two different patients.No patient was harmed, injured, or maltreated hence no adverse event.Calibration as well as qc showed no problem at all.Patient 1 (female, (b)(6)): sample (b)(4); (b)(6) 2021; 05:17 a.M.; k=11,3 mmol/l value does not match with patient's status.Comparison measurement at customer's lab showed a plausible value k= 3,9 mmol/l.Patient 2 (female, (b)(6)): sample (b)(4); (b)(6) 2021; 07:25 a.M.; k=7,4 mmol/l value does not match with patient's status.Comparison measurement at customer's lab showed a plausible value k= 4,25 mmol/l.
 
Manufacturer Narrative
According to the complaint the issue was resolved by cleaning of measuring chamber and replacement of reference membrane as well as k+ membrane.Based on that the incident is assessed to be caused by a component failure.Due to lack of information it has not been possible to determine the component or root cause.
 
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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 Key12382815
MDR Text Key268739288
Report Number3002807968-2021-00033
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 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
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? Yes
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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