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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX; BLOOD GAS ANALYZER

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RADIOMETER MEDICAL APS ABL90 FLEX; BLOOD GAS ANALYZER Back to Search Results
Model Number ABL90 FLEX
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2014
Event Type  malfunction  
Event Description
A patients ica was run o the abl90 (with serial # (b)(4)it was reported to be 2.07 mg/dl.Because it was critically low the staff questioned the result and repeated it on another abl90 (serial # (b)(4)).It was reported to be 4.60 mg/dl on the second analyzer.There was no reported injury, diagnosis or treatment based on the low calcium result.
 
Manufacturer Narrative
The data logs from the analyzer has been received and are being investigated.When a conclusion has been obtained the result will be reported.The failing sensor cassette has also been requested sent back for investigation.If received the results of this investigation will also be reported.
 
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Brand Name
ABL90 FLEX
Type of Device
BLOOD GAS ANALYZER
Manufacturer (Section D)
RADIOMETER MEDICAL APS
bronshoj 2700
DA  2700
Manufacturer Contact
akandevej 21
bronshoj 2100
8273827
MDR Report Key4260877
MDR Text Key4987064
Report Number3002807968-2014-00056
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberABL90 FLEX
Device Catalogue Number393-090
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/14/2014
Initial Date FDA Received11/15/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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