MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-08 for SOFIA STREP A+ FIA 20274 manufactured by Quidel Corporation.
[107634213]
The test and reagent vial were not returned to quidel for evaluation. However, the qc department evaluated retained vials from the same lot. All vials met the inspection criteria - free of holes, splits, etc. No leakage or moisture was evident. A sample of vials were opened per the instructions for use, and no issues were observed.
Patient Sequence No: 1, Text Type: N, H10
[107634214]
When opening a strep a reagent solution vial, the solution splashed into the right eye of the operator which caused stinging and burning. The operator went to a doctor who provided antibiotic eye drops. The eye healed in two days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024674-2018-00002 |
| MDR Report Key | 7495325 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER RIAL |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585527910 |
| Manufacturer G1 | QUIDEL CORPORATION |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFIA STREP A+ FIA |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2018-05-08 |
| Model Number | 20274 |
| Lot Number | 703212 |
| Device Expiration Date | 2018-11-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORPORATION |
| Manufacturer Address | 10165 MCKELLAR COURT SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-08 |