MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-29 for AMPCOR * manufactured by Ampcor Technologies Inc. (ati.
[165899]
Since using the ampcor rpr kit in april-may 2000 a 30% decrease (3. 5% to 2. 2%) in rpr positivity rate has been observed. The lab has received complaints of titers being too low. The parallel test of ampcor antigen vs. Asi and bd antigen failed in one of three laboratories. A 20% drop (9. 25% to 7. 4%) in confirmed positives (positive fta's/total specimens tested) has also been observed for that time period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 286009 |
| MDR Report Key | 286009 |
| Date Received | 2000-06-29 |
| Date of Report | 2000-06-27 |
| Date of Event | 2000-06-20 |
| Date Facility Aware | 2000-06-20 |
| Report Date | 2000-06-27 |
| Date Reported to FDA | 2000-06-27 |
| Date Reported to Mfgr | 2000-06-27 |
| Date Added to Maude | 2000-07-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPCOR |
| Generic Name | RPR TEST KIT |
| Product Code | MYR |
| Date Received | 2000-06-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 1138 |
| ID Number | * |
| Device Expiration Date | 2001-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276762 |
| Manufacturer | AMPCOR TECHNOLOGIES INC. (ATI |
| Manufacturer Address | 100 FORD RD DENVILLE NJ 07834 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-29 |