MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-28 for GAMMA PEG manufactured by Immucor.
[1238333]
Customer reported unexpected negative reactions on a patient sample. Manual tube testing using peg for antibody screen and panel were both negative.
Patient Sequence No: 1, Text Type: D, B5
[8314091]
According to the package insert, negative reactions will be obtained if the test serum contains antibodies present in a concentration too low to be detected by the test method employed. The customer does not have any sample to send in for investigation testing. The event appears to be due to the nature of the sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2009-00325 |
| MDR Report Key | 1483939 |
| Report Source | 05,06 |
| Date Received | 2009-09-28 |
| Date of Report | 2009-09-25 |
| Date of Event | 2009-09-01 |
| Date Mfgr Received | 2009-09-01 |
| Date Added to Maude | 2009-12-17 |
| 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 | IMMUCOR 3150 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 | 3 |
| 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 | 2009-09-28 |
| Lot Number | 336010 |
| Device Expiration Date | 2010-05-22 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091 US 30091 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-28 |