MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-09-12 for CAPTURE-S manufactured by Immucor, Inc..
[684820]
Customer reported unexpected negative reactions with capture-s indicator cells. A donor sample was run on galileo twice; it was reactive. The same sample was run with a different lot of indicator cells and it was nonreactive. There was no history available on the donor.
Patient Sequence No: 1, Text Type: D, B5
[7864946]
Testing was performed on an in-house galileo with capture-s, lots s106 and s108 and capture-s indicator red cells, lot 229047 using in-house donor samples and the customer's donor sample. In-house donor samples were nonreactive in all testing. The customer's donor sample was nonreactive in all galileo testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2007-00222 |
| MDR Report Key | 910317 |
| Report Source | 05,06 |
| Date Received | 2007-09-12 |
| Date of Report | 2007-09-11 |
| Date of Event | 2007-08-13 |
| Date Mfgr Received | 2007-08-13 |
| Date Added to Maude | 2007-09-12 |
| 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. SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-S |
| Generic Name | NONTREPONEMAL ANTIGENS |
| Product Code | GMQ |
| Date Received | 2007-09-12 |
| Lot Number | 229046 |
| Device Expiration Date | 2007-08-10 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 884083 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-12 |