MalfunctionKSS
CAPTURE-R SELECT PLATE
Received Aug 7, 2008 · Event occurred Jul 9, 2008
Report 1034569-2008-00287 · MDR key 1097776
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Reaction
Narrative
Description of Event or Problem
CUSTOMER REPORTED A TRANSFUSION REACTION OCCURRED ON A PATIENT WHOSE SAMPLE WAS TESTED WITH CAPTURE-R SELECT ON GALILEO.
Additional Manufacturer Narrative
THE INSTRUMENT IMAGES WERE REVIEWED, THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SAMPLE AND REAGENTS WERE NOT AVAILABLE FOR REPEAT TESTING; CAPTURE REAGENTS HAD EXPIRED. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.