MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-29 for PRODIGY AUTO CODE manufactured by Ok Biotech Company Ltd.
| Report Number | 3008789114-2020-00015 |
| MDR Report Key | 9895092 |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-03-11 |
| Date Facility Aware | 2020-03-13 |
| Report Date | 2020-03-29 |
| Date Reported to FDA | 2020-03-29 |
| Date Reported to Mfgr | 2020-03-29 |
| Date Added to Maude | 2020-03-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODIGY AUTO CODE |
| Generic Name | BLOOD GLUCOSE MONITORING DEVICE |
| Product Code | NBW |
| Date Received | 2020-03-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OK BIOTECH COMPANY LTD |
| Manufacturer Address | NO. 91, SEC 2 GONGDAO 5TH RD HSINCHU CITY, 30070 TW 30070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-29 |