MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-29 for QUIDEL STREP A TEST 1094000 manufactured by Quidel Corp..
[3281790]
The quidel rapid quickvue in-line strep test does not complete the drawing of the liquid out of the well, or the liquid leaks out of the sides of the test container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028869 |
| MDR Report Key | 2949476 |
| Date Received | 2013-01-29 |
| Date of Report | 2013-01-29 |
| Date of Event | 2013-01-25 |
| Date Added to Maude | 2013-02-14 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUIDEL STREP A TEST |
| Generic Name | RAPID STREP TEST |
| Product Code | GTZ |
| Date Received | 2013-01-29 |
| Returned To Mfg | 2013-01-29 |
| Model Number | 1094000 |
| Catalog Number | 1094000 |
| Lot Number | 211749 |
| Device Expiration Date | 2014-05-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORP. |
| Manufacturer Address | 10165 MCKELLAR CT. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-29 |