MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-20 for PRO ADVANTAGE STREP A DIPSTICK (25T) P080033 manufactured by Alere San Diego, Inc..
[136889124]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[136889125]
Unspecified date: patient presented to emergency room with symptoms consistent with strep. A throat culture was collected using a dual swab technique and tested on the proadvantage strep a kit which provided a (b)(6) result. No treatment was provided based on the (b)(6) result. The alternate swab was sent for confirmatory testing on the same day, however, the results were not obtained until a few days later. The result of the confirmatory culture was (b)(6). Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00024 |
| MDR Report Key | 8356194 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-20 |
| Date of Report | 2019-05-08 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE RD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO ADVANTAGE STREP A DIPSTICK (25T) |
| Generic Name | STREP A RAPID TEST STRIP |
| Product Code | GTY |
| Date Received | 2019-02-20 |
| Model Number | P080033 |
| Lot Number | STA8050080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE RD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |