MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-21 for QUICK-VUE DIPSTICK STREP A manufactured by Quidel.
[30032089]
Using our quidel strep a kit, we have had numerous faint test lines. We have been reporting these tests as positive as per the instructions. On our last proficiency test we failed one of the specimens. We reported it as positive, albeit a very weak one. Since that result we have sent our weak positives in for culture verification. So far we have two positive and two negative. We are still waiting on several more results. How do we know if we are resulting correctly if the cultures are only confirming 50%. It appears that quidel had more positives to that particular specimen than any other manufacturer. Are they much more sensitive or are they cross-reacting and giving false positives.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057568 |
| MDR Report Key | 5191405 |
| Date Received | 2015-10-21 |
| Date of Report | 2015-10-21 |
| Date Added to Maude | 2015-10-30 |
| 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 | QUICK-VUE DIPSTICK STREP A |
| Generic Name | QUICK-VUE DIPSTICK STREP A |
| Product Code | GTY |
| Date Received | 2015-10-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-21 |