PEG
Received May 1, 2012 · Event occurred Apr 2, 2012
Report 1034569-2012-00083 · MDR key 2554404
Device
Generic name
Antibody Potentiating Reagent
Manufacturer
Immucor, Inc.Catalog number
0705010
Lot number
336017
Product problems
- False Negative Result
Patient
76 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS IN MANUAL TESTING USING PEG FOR ANTIBODIES THAT WERE WEAKLY REACTIVE ON THE GALILEO ECHO INSTRUMENT.
Additional Manufacturer Narrative
A NEW LOT OF PEG WAS SHIPPED TO THE CUSTOMER. NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER WASHES MANUALLY AND MAY NOT BE ADEQUATELY WASHING CELLS. THE WEAKNESS OF THE REACTIONS ON THE ECHO, AND THE LACK OF REACTIVITY IN GEL, POINT TO THE FACT THAT THIS IS A WEAK EXPRESSION OF THE ANTIBODY WHICH MAY BE BELOW THE THRESHOLD OF REACTIVITY, ESPECIALLY IF LESS THAN OPTIMAL TEST CONDITIONS EXIST. THE FOLLOWING LIMITATIONS SECTION LOCATED IN THE PACKAGE INSERT WAS REVIEWED WITH THE CUSTOMER: "POLYETHYLENE GLYCOL HAS A TENDENCY TO PRECIPITATE SERUM GLOBULINS. ACCORDINGLY, WHEN USING GAMMA PEG TO DETECT UNEXPECTED ANTIBODIES, IT IS ESPECIALLY IMPORTANT TO ASSURE THAT THE RED BLOOD CELLS ARE THOROUGHLY RESUSPENDED IN EACH CHANGE OF SALINE DURING THE WASHING PHASES OF THE TEST." THE PRODUCT IS PERFORMING AS EXPECTED.