MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-03 for CAPTURE-S * manufactured by Immucor, Inc..
[513102]
Customer states that they are getting unexpected negative reactions with positive control cells, lot # 252008, exp. 2/11/07 of capture s when performing their lot to lot qc capture s indicator cells, lot #229018.
Patient Sequence No: 1, Text Type: D, B5
[7799476]
The customer's previous lot of positive control, lot #252006, and negative control, lot #251005, used for daily quality control performed as expected, using the same lot of indicator cells. The old lots of controls tested with a new lot of indicator cells, lot #229019, performed as expected. Retention capture -s indicator cells, lot 229018 were tested on an in-house semi-automated instrument with retention capture-s plates, lot s098; capture-s reactive control serum, lot 252007; capture-s nonreactive control serum, lot 251006 and in-house donor samples. In-house donor samples were nonreactive in all testing performed, as expected. Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2006-00075 |
| MDR Report Key | 761444 |
| Report Source | 06 |
| Date Received | 2006-08-03 |
| Date of Report | 2006-08-02 |
| Date of Event | 2006-07-14 |
| Date Mfgr Received | 2006-07-14 |
| Date Added to Maude | 2006-09-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DR |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | FA-06-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-S |
| Generic Name | GMQ |
| Product Code | GMQ |
| Date Received | 2006-08-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 229018 |
| ID Number | * |
| Device Expiration Date | 2006-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749351 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | * NORCROSS GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-03 |