DADE ACTIN FSL
Received Feb 21, 2007 · Event occurred Jan 31, 2007
Report 9610806-2007-00002 · MDR key 843140
Device
Generic name
Activated Ptt Reagent
Manufacturer
Dade Behring GmbhModel number
NACatalog number
B4219-2
Lot number
527338A
Product problems
- Incorrect Or Inadequate Test Results
Patient
YR
- Bleeding
- Treatment with medication(s)
Narrative
Description of Event or Problem
A FALSELY DEPRESSED APTT RESULT OF 20 SEC. WAS OBTAINED ON A SAMPLE FROM A PATIENT RECEIVING HEPARIN. DESPITE THE RESULTS BEING FLAGGED BY THE INSTRUMENT, THE CUSTOMER REPORTED THEM TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULTS. A NEW SAMPLE WAS TESTED AND A RESULT OF 75 SEC. WAS OBTAINED. THE 75 SEC. RESULT WAS CONFIRMED BY ALTERNATE METHODOLOGY. THE PATIENT RECEIVED A BOLUS OF HEPARIN AND BLED. NO PERMANENT HARM WAS DONE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE FALSELY DEPRESSED APTT WAS USER ERROR.
Additional Manufacturer Narrative
NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE FALSELY DEPRESSED APTT WAS USER ERROR. THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS
Remedial action
- Other