MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-31 for SURE-VUE SERUM/URINE HCG SA087701 SA087750 manufactured by Fisher Scientific.
[460714]
Sure-vue pregnancy test is advertised as sensitive to 25 miu/ml. Test device package says 4 drops 4 minute read. Insert indicated a line appearing between 4 & 15 minutes may be positive for hcg. Rptr's date show test not sensitive to 25 miu/ml at 4 minutes. Test info is confusing to the point of being false.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037885 |
| MDR Report Key | 680112 |
| Date Received | 2006-01-31 |
| Date Added to Maude | 2006-03-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURE-VUE SERUM/URINE HCG |
| Generic Name | SURE-VUE PREGNANCY TEST |
| Product Code | JHJ |
| Date Received | 2006-01-31 |
| Model Number | SA087701 |
| Catalog Number | SA087750 |
| Lot Number | VARIOUS |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669383 |
| Manufacturer | FISHER SCIENTIFIC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-01-31 |