MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-01 for PEG 0705010 manufactured by Immucor, Inc..
[20747244]
A customer reported obtaining unexpected negative reactions in manual testing using peg for antibodies that were weakly reactive on the galileo echo instrument.
Patient Sequence No: 1, Text Type: D, B5
[20968284]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2012-00083 |
| MDR Report Key | 2554404 |
| Report Source | 05,06 |
| Date Received | 2012-05-01 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-04-02 |
| Date Mfgr Received | 2012-04-02 |
| Device Manufacturer Date | 2010-08-26 |
| Date Added to Maude | 2012-06-13 |
| 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 SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 5625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEG |
| Generic Name | ANTIBODY POTENTIATING REAGENT |
| Product Code | KSG |
| Date Received | 2012-05-01 |
| Catalog Number | 0705010 |
| Lot Number | 336017 |
| Device Expiration Date | 2012-08-26 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091562 US 30091 5625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-01 |