MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-07-24 for CAPTURE-S * manufactured by Immucor, Inc..
[524075]
Customer reports that they are getting unexpected negative reactions for syphilis testing with capture-s reactive control serum when using capture-s indicator cells, lot 229018. The first testing run performed as expected, but the 2nd testing run gave negative reactions with the reactive control. The customer also reported that they were getting some reactive syphilis test results with pt samples; these results were confirmed using rpr testing. No medical action was taken based on the unexpected negative results.
Patient Sequence No: 1, Text Type: D, B5
[7849121]
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-houe donor samples were nonreactive, as expected. Capture-s reactive control serum, lot 252007 was tested as a control and as test samples. Capture-s reactive control serum was interpreted as reactive when used as a control sample with retention lot of capture-s indicator cells; it was interpreted as equivocal when read as a control sample using the returned capture-s indicator cells. The capture-s reactive control serum was interpreted as equivocal in all testing when tested as a test sample. Investigation is ongoing. Manual capture-s testing was performed. Visual scoring of capture-s reactive control serum was 4 to 6, reactive. Capture-s nonreactive control serum was nonreactive, as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2006-00066 |
| MDR Report Key | 745305 |
| Report Source | 06 |
| Date Received | 2006-07-24 |
| Date of Report | 2006-07-24 |
| Date of Event | 2006-06-30 |
| Date Mfgr Received | 2006-06-30 |
| Date Added to Maude | 2006-08-10 |
| 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 | J. 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 | 2006-07-24 |
| 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 | 733094 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | * NORCROSS GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-24 |