MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-13 for CAPTURE-S manufactured by Immucor, Inc..
[22122548]
Customer reported that seven known syphilis positive samples were nonreactive on the galileo with the capture-s assay.
Patient Sequence No: 1, Text Type: D, B5
[22255080]
Investigation determined that the customer used a lot of capture-s indicator cells to perform testing that had been the subject of a recall. In-house testing demonstrated that 4 of the 7 samples were reactive with the capture-s assay. The original testing was performed with the olympus pk tp assay, which is a treponemal antigen based assay and 3 of those samples were rpr reactive; the rpr is a nontreponemal based assay for syphilis. Capture-s is a nontreponemal antigen based assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2008-00553 |
| MDR Report Key | 1226185 |
| Report Source | 05,06 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-07 |
| Date of Event | 2008-10-20 |
| Date Mfgr Received | 2008-10-20 |
| Date Added to Maude | 2009-03-30 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 06-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-S |
| Generic Name | NONTREPONEMAL SYPHILIS TEST |
| Product Code | GMQ |
| Date Received | 2008-11-13 |
| Lot Number | 299018 |
| 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 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-13 |