MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-14 for QUICKVUE+ * 00179 manufactured by Quidel Corp..
[337899]
An error in labeling on the quickvue+ urine pregnancy test kit was brought to rptr attention recently. To perform the test you need to add 4 -four- drops of urine to the test card. This is clearly stated in the package insert, the laminated procedure card that comes inside the box, and rptr's policy. The problem is on the test card itself -there's a picture of a dropper with 3 drops coming out of it. This may cause confusion as to how many drops of urine are required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032104 |
| MDR Report Key | 528068 |
| Date Received | 2004-05-14 |
| Date of Report | 2004-05-14 |
| Date Added to Maude | 2004-06-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | QUICKVUE+ |
| Generic Name | URINE PREGNANCY TEST KIT |
| Product Code | JHJ |
| Date Received | 2004-05-14 |
| Model Number | * |
| Catalog Number | 00179 |
| Lot Number | 147653 |
| ID Number | * |
| Device Expiration Date | 2005-09-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 517256 |
| Manufacturer | QUIDEL CORP. |
| Manufacturer Address | * SAN DIEGO CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-14 |