MalfunctionGJG
MTS DISPENSER 0.5ML
Received Apr 19, 2007 · Event occurred Mar 20, 2007
Report 1056600-2007-00099 · MDR key 939972
Device
Generic name
Manual Dispenser
Manufacturer
Micro Typing Systems, Inc.Model number
NACatalog number
MTS9610
Lot number
40295
Product problems
- Volume Accuracy Problem
Patient
*
- Therapy/non-surgical treatment, aborted/stopped
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT MTS DISPENSER DID NOT DISPENSE THE CORRECT AMOUNT OF FLUID DURING TESTING. INCORRECT DISPENSE OF FLUID, MAY LEAD TO VARIATIONS IN ANTIGEN / ANTIBODY RATIO AND POSSIBLE ERRONEOUS TEST RESULTS. THE CUSTOMER ABORTED TESTING ONCE THE ISSUE WAS IDENTIFIED. THE DISPENSER WAS TAKEN OUT OF USE, PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED.
Additional Manufacturer Narrative
THE DISPENSER WAS NOT RETURNED FOR INVESTIGATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. ISSUE RESOLVED VIA PRODUCT REPLACEMENT.