AXSYM CMV-G REAGENT KIT
Received Aug 2, 2006 · Event occurred Jul 19, 2006
Report 1415939-2006-00018 · MDR key 761898
Device
Generic name
In Vitro Test Kit For Cmv Antibodies
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
4B47-20
Lot number
31293M200
Product problems
- False Negative Result
- Low Test Results
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED AN INITIAL AXSYM CMV IGG ASSAY RESULT OF 73.5 AU/ML. THE SAMPLE WAS LATER RETESTED WITH LOT 31293M200 AND GENERATED AN AXSYM CMV IGG ASSAY RESULT OF 0 AU/ML. THE CUSTOMER THEN TESTED THE SAMPLE WITH A THIRD (DIFFERENT) LOT OF REAGENT AND GENERATED AN AXSYM CMV IGG ASSAY RESULT CLOSE TO THE FIRST RESULT OF 73.5 AU/ML (THE CUSTOMER DID NOT GIVE ANY INFO CONCERNING THE OTHER LOTS USED IN TESTING). THE CUSTOMER STATED THAT OVERALL, LOT 31293M200 GENERATES LOWER TEST RESULTS THAN OTHER LOTS USED IN THE LAB. CONTROLS HAVE REMAINED WITHIN SPECIFICATINS WITH ALL LOTS OF REAGENT IN USE. THERE IS NO IMPACT TO PT MGMT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.