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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 pH (4005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/31/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020 a customer measured a patient samples on an abl800 analyzer where the ph measurement results were false low.At the measurement time, the customer did not notice but due to the continuous lower ph values, they noticed something were wrong.At least, sample id (b)(4) were lower than the doctor's expectation and did not match the patient's condition.The doctor was expected the patient to have ph values in the normal range.No comparison measurements are available.Sample id (b)(4): (b)(6) 2020 10:16 - 7.331, (b)(6) 2020 09:40 - 7.310, (b)(6) 2020 09:31 - 7.370, (b)(6) 2020 09:26 - 7.261, (b)(6) 2020 09:22 - 7.187, (b)(6) 2020 09:11 - 7.256, (b)(6) 2020 08:56 - 7.161, (b)(6) 2020 08:35 - 7.126, (b)(6) 2020 08:24 - 7.151, (b)(6) 2020 07:50 - 7.238.The patient was incorrectly treated based on these false low values.Fortunately, the treatment had no serious outcome for patient.
 
Manufacturer Narrative
According to the investigation performed it was identified that the low ph measurement was due to a blood clot under the ph electrode.
 
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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 Key9980194
MDR Text Key225481854
Report Number3002807968-2020-00014
Device Sequence Number1
Product Code CHL
UDI-Device Identifier05700693938004
UDI-Public(01)05700693938004(10)754R2668N011
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 05/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
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 Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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