MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-08-21 for CONSULT STREP A DIPSTICK 5003 25T IST-501 manufactured by Alere San Diego.
| Report Number | 2027969-2019-00240 |
| MDR Report Key | 8918993 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-08-21 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 ROAD |
| 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 | CONSULT STREP A DIPSTICK 5003 25T |
| Generic Name | STREP A TEST |
| Product Code | GTY |
| Date Received | 2019-08-21 |
| Returned To Mfg | 2019-09-24 |
| Model Number | IST-501 |
| Lot Number | MULTIPLE LOT NUMBERS-SEE H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO |
| Manufacturer Address | 9995 SUMMERS RIDGE RD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-21 |