OtherKSO
ID-MTS READER SA
Received Nov 11, 2003 · Event occurred Oct 4, 2003
Report 1058138-2003-00010 · MDR key 496631
Device
Generic name
Blood Grouping Centrifuge And Reader
Manufacturer
Micro Typing Systems, Inc.Model number
MTS9945Catalog number
MTS READER SA
Lot number
NA
Product problems
- False Negative Result
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED OBTAINING WEAK D NEGATIVE RESULTS WITH THE MTS READER SA WITH A KNOWN WEAK D POSITIVE DONOR. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.
Remedial action
- Other