MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-21 for GAMMA PEG manufactured by Immucor, Inc.
[1086186]
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.
Patient Sequence No: 1, Text Type: D, B5
[8433292]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2009-00247 |
| MDR Report Key | 1417048 |
| Report Source | 05,06 |
| Date Received | 2009-07-21 |
| Date of Report | 2009-07-17 |
| Date of Event | 2009-06-23 |
| Date Mfgr Received | 2009-06-23 |
| Date Added to Maude | 2009-09-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. J. WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091 |
| Manufacturer Country | US |
| Manufacturer Postal | 30091 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMMA PEG |
| Generic Name | ANTIBODY POTENTIATING REAGENT |
| Product Code | KSG |
| Date Received | 2009-07-21 |
| Lot Number | 336012 |
| Device Expiration Date | 2010-09-19 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC |
| Manufacturer Address | 3130 GATEWAY DR NORCROSS GA 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-21 |