GAMMA PEG
Received Jul 21, 2009 · Event occurred Jun 23, 2009
Report 1034569-2009-00247 · MDR key 1417048
Device
Product problems
- False Negative Result
Patient
79 YR
- No Information
Narrative
Description of Event or Problem
CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY WHEN TETING PATIENTS WITH ANTI-D WHEN USING GAMMA PEG. IT IS NOT HELPING THE DETECTION OF WEAKLY REACTIVE ANTI-D ANTIBODIES, SUCH AS RH IMMUNE GLOBULIN IN PATIENT SAMPLES. THE CUSTOMER ALSO HAD A PATIENT WHO SEEMS TO HAVE ANTI-D REACTING WELL IN GEL (4+) BUT NOT AT ALL USING PEG. PATIENT NEVER RECEIVED UNSUITABLE UNITS FOR TRANSFUSION.CUSTOMER IS NOT HAVING PROBLEMS PICKING UP OTHER THAN ANTI-D ANTIBODIES.
Additional Manufacturer Narrative
HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED PATIENT SAMPLE USING RETENTION PANOSCREEN I, II, AND III, LOT 20442. RETENTION PEG, LOTS 336011 AND 336012, WERE USED AS POTENTIATORS. SAMPLE EXHIBITED WEAK REACTIVITY (1+) WITH D-POSITIVE CELLS AND WAS NONREACTIVE WITH D-NEGATIVE CELL.HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH 2 ADDITIONAL RETURNED PATIENT SAMPLES, USING D-POSITIVE, FY(A-), JK(A-) CELL 3 AND D-NEGATIVE, FY(A-), JK(A-) CELL 16 FROM RETENTION PANOCELL-20, LOT 21467. RETENTION PEG, LOTS 336011 AND 336012, WERE USED AS POTENTIATORS. BOTH SAMPLES EXHIBITED WEAK REACTIVITY (1+) WITH D-POSITIVE CELL AND WERE NONREACTIVE WITH D-NEGATIVE CELL.