MalfunctionKSG
GAMMA PEG
Received Sep 28, 2009 · Event occurred Sep 1, 2009
Report 1034569-2009-00325 · MDR key 1483939
Device
Product problems
- False Negative Result
Patient
33 YR
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE. MANUAL TUBE TESTING USING PEG FOR ANTIBODY SCREEN AND PANEL WERE BOTH NEGATIVE.
Additional Manufacturer Narrative
ACCORDING TO THE PACKAGE INSERT, NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN A CONCENTRATION TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED. THE CUSTOMER DOES NOT HAVE ANY SAMPLE TO SEND IN FOR INVESTIGATION TESTING. THE EVENT APPEARS TO BE DUE TO THE NATURE OF THE SAMPLE.