D
Patient 1
CUSTOMER REPORTED A PATIENT SAMPLE WITH MULTIPLE ANTIBODIES WAS NONREACTIVE WHEN TESTING WAS PERFORMED USING GAMMA N-HANCE. THE PATIENT HAS A HISTORY OF ANTI-K, ANTI-C, ANTI-E AND A WARM AUTOANTIBODY.
MAUDE MDR 1670620
- MDR report key
- 1670620
- Report number
- 1034569-2010-00104
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-04-02
- Date received
- 2010-04-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 105
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. J. WEBBER
- Address
- IMMUCOR 3150 GATEWAY DRIVE NORCROSS GA 30091 US
- Phone
- 770-770-7704
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-04-30 | 0 |
Event Narratives#
N
Patient 1
REVIEW OF ANTIBODY SCREEN WITH N-HANCE SHOWS THAT ALL CELLS RESULTED NEGATIVE. TESTED A SAMPLE WITH KNOWN IGG ANTIBODY (ANTI-FYA) USING RETENTION N-HANCE, LOT 335007 AND WITHOUT N-HANCE AS THE POTENTIATOR, USING RETENTION PANOSCREEN I, II AND III. THE ANTIBODY WAS ENHANCED FROM 2+ TO 3+ REACTIVITY WITH THE USE OF RETENTION N-HANCE AS THE POTENTIATOR AT THE INDIRECT ANTIGLOBULIN TEST. RETENTION PRODUCTS PERFORMED AS EXPECTED. TESTED A SAMPLE WITH KNOWN IGG ANTIBODY (ANTI-FYA) USING RETURNED N-HANCE, LOT 335007 AND WITHOUT N-HANCE AS THE POTENTIATOR ON RETENTION PANOSCREEN I, II AND III. THE ANTIBODY WAS ENHANCED FROM 2+ TO 3+ REACTIVITY WITH THE USE OF RETURNED N-HANCE AS THE POTENTIATOR AT THE INDIRECT ANTIGLOBULIN TEST. RETURNED PRODUCTS PERFORMED AS EXPECTED. THE SUBMITTED PATIENT SAMPLE WAS TESTED WITH RETENTION PANOSCREEN I, II AND III USING THREE SETS OF TESTING PARAMETERS: SET A -WITHOUT N-HANCE; SET B - WITH RETENTION N-HANCE; SET C - WITH RETURNED H-HANCE. THE RESULTS WERE AS FOLLOWS: SET A - THE SAMPLE EXHIBITED NO REACTIVITY MACRO/MICRO AT THE INDIRECT ANTIGLOBULIN TEST (IAT) SET B - THE SAMPLE EXHIBITED VERY WEAK TO MICROSCOPIC REACTIVITY WITH CELL I, E-,C-, K- REAGENT RED CELLS ONLY. NO REACTIVITY WAS OBSERVED WITH CELL II AND III. SET C - THE SAME REACTIVITY WAS OBSERVED AS SET B. THE RETURNED SAMPLE WAS TESTED WITH RETENTION PANOSCREEN I, II AND III USING RETENTION PEG. THE SAMPLE EXHIBITED WEAK REACTIVITY WITH CELL I AND II AND 1+ REACTIVITY WITH CELL III. THE SAMPLE WAS TESTED WITH RETENTION CAPTURE-R READY SCREEN 3 , LOT R084 ON OUR IN-HOUSE ECHO. THE SAMPLE EXHIBITED 4+ REACTIVITY WITH ALL THREE REAGENT RED CELLS. IT APPEARS THAT BASED ON THE ABOVE RESULTS, THE ANTIBODY THAT IS VERY WEAKLY DETECTED WITH RETURNED AND RETENTION N-HANCE IS THE WARM AUTO ANTIBODY. PREVIOUS ANTI-E, -C AND -K WERE NOT DETECTED. THE WARM AUTO ANTIBODY WAS ALSO DETECTED WEAKLY USING PEG AND IN CAPTURE ASSAY.