CAPTURE-P
Received Sep 21, 2016 · Event occurred Sep 1, 2016
Report 1034569-2016-00244 · MDR key 5966769
Device
Generic name
Solid Phase System For The Detection Of Igg Antibodies To Platelets
Manufacturer
Immucor, Inc.Catalog number
0066246
Lot number
P171
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CAPTURE-P PROCESS IS A MANUAL USER PROCESS. IMMUCOR TECHNICAL SUPPORT USED PHONE SUPPORT. NO BLOOD SAMPLE OR CUSTOMER SITE PRODUCT WAS RETURNED TO IMMUCOR FOR INVESTIGATION. THE CUSTOMER COMMENTED THAT THE MEMBER OF STAFF PERFORMING THE ORIGINAL MANUAL TESTING WAS A TRAINEE AND THE CUSTOMER DETERMINED THAT THEY HAD MADE A USER SAMPLE ADDITION ERROR. MANUAL USER PROCESS WITH PHONE SUPPORT.
Description of Event or Problem
ON (B)(6) 2016, A CUSTOMER SITE REPORTED TEN (10) UNEXPECTED NEGATIVE PLATELET CROSSMATCH TESTS WHEN TESTED AGAINST ONE SINGLE BLOOD SAMPLE, WHEN USING CAPTURE-P.