MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-24 for QUIDEL QUICKVUE IN LINE STREP KIT 00343 US manufactured by Quidel.
[55887225]
Failed cap unknown survey sample #(b)(4). Also failed cap unknown survey sample (b)(4) on (b)(6) 2016. Both samples tested negative at our facility and should have been positive. I looked back at both survey summary of manufacturers listed in the cap survey set d9-a and d9-b and the quidel quickvue in-line group a strep test kit appeared to have an elevated percentage of false negatives verses most other kits listed. We culture all negative strep tests here at our facility and i found we had a false negative rate of 12 percent over the months of (b)(6) 2016. We decided to purchase a different test kit and now do group a strep testing with the quidel quickvue dipstick kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065029 |
| MDR Report Key | 5979721 |
| Date Received | 2016-09-24 |
| Date of Report | 2016-09-24 |
| Date of Event | 2016-08-16 |
| Date Added to Maude | 2016-09-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUIDEL QUICKVUE IN LINE STREP KIT |
| Generic Name | QUIDEL QUICKVUE IN LINE STREP KIT |
| Product Code | GTZ |
| Date Received | 2016-09-24 |
| Catalog Number | 00343 US |
| Lot Number | 702109 |
| Device Expiration Date | 2017-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL |
| Manufacturer Address | SAN DIEGO CA 92130 US 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-24 |