TDX/TDXFLX FLM II
Received Aug 3, 2007 · Event occurred Jul 5, 2007
Report 1415939-2007-00205 · MDR key 889966
Device
Generic name
Fpa For The Assessment Of Lung Maturity Of The Fetus
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
7A76-50
Lot number
51325M200
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
NA YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
THE CUSTOMER STATED THAT A BARCODE MISREAD ON THE TDX/TDXFLXFLM II REAGENT PACK. A CALIBRATION WAS PERFORMED USING A FLM II REAGENT PACK BUT UPON REVIEW OF THE CALIBRATION, THEY NOTED ETHOSUXIMIDE WAS CALIBRATED INSTEAD OF FLM II. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE HAD THE CUSTOMER CLEAN THE REAGENT BARCODE AND THE BARCODE READER TO RESOLVE THE ISSUE. NO PATIENT RESULTS WERE GENERATED AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.