MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-09-02 for QUICK IN-LINE STREP A TEST KIT 00343 manufactured by Quidel Corporation.
[2384645]
Two (b)(6) females experienced allergic reactions while using the extraction reagents in the quickvue in-line strep a test kit. The individuals developed an allergy to the reagents but unk after how may uses. Allergic reactions occurred when they just started using the kit about four months ago. Symptoms included red eyes, difficulty breathing, wheezing, and probably rapid breathing. Reagents did not come into direct contact with the individuals. One female used ventolin inhalations and arubant (also known as aerovent long-acting bronchodilators). The second female also used ventolin inhalations and stayed home for a few days until the allergic reaction passed. Both individuals are reported to have recovered from the events.
Patient Sequence No: 1, Text Type: D, B5
[9460494]
These appear to be isolated events involving individuals with severe allergies. There are no known allergic issues with the kit reagents.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024674-2011-00001 |
| MDR Report Key | 2237927 |
| Report Source | 01,08 |
| Date Received | 2011-09-02 |
| Date of Report | 2011-09-01 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-08-04 |
| Date Added to Maude | 2011-09-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 10165 MCKELLAR COURT |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8585527910 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUICK IN-LINE STREP A TEST KIT |
| Generic Name | QUICKVUE IN-LINE STEP A TEST KIT |
| Product Code | GTZ |
| Date Received | 2011-09-02 |
| Model Number | NA |
| Catalog Number | 00343 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUIDEL CORPORATION |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2011-09-02 |