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..
[140320326]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
[140320327]
Unspecified date: young girl presented to er 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 negative result. No treatment was provided based on the false negative result. The alternate swab was sent for confirmatory testing on the same day, however, the results were not obtained until three days later. The result of the confirmatory culture was positive. During that three day period, the girl attended school potentially exposing other children to strep. Although further information was requested, no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2019-00022 |
| MDR Report Key | 8356214 |
| 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 |