MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-08-15 for CAPTIA SYPHILIS IGG * 800-925,801-030,801032,801-033 manufactured by Trinity Biotech.
[19783774]
Blood and/or plama samples tested with affected lots of product may provide a false negative result. This is due to a shift in performance of the low titre reaction control. No false negative results have been reported to date. Product tests for syphilis ige.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681576-2002-00001 |
| MDR Report Key | 410368 |
| Report Source | 05 |
| Date Received | 2002-08-15 |
| Date of Report | 2002-06-12 |
| Date of Event | 2002-06-01 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2002-08-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FIONA CAMPBELL |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | BRAY, CO. WICKLOW |
| Manufacturer Country | EI |
| Manufacturer Phone | 12769800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1186-2 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTIA SYPHILIS IGG |
| Generic Name | IN VIVO DIAGNOSTIC |
| Product Code | GMQ |
| Date Received | 2002-08-15 |
| Model Number | * |
| Catalog Number | 800-925,801-030,801032,801-033 |
| Lot Number | K00838, K00839, K00840, K00841 |
| ID Number | * |
| Device Expiration Date | 2003-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 399377 |
| Manufacturer | TRINITY BIOTECH |
| Manufacturer Address | IDA BUSINESS PARK BRAY, CO. WICKLOW EI |
| Baseline Brand Name | CAPTIA SYPHILIS IGG |
| Baseline Generic Name | IN VILVO DIAGNOSTIC |
| Baseline Model No | * |
| Baseline Catalog No | 800-925,801-030,801032,801-033 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-15 |