MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for OT VERIO IQ METER 022-275 manufactured by Lifescan Europe Gmbh.
| Report Number | 2939301-2020-02609 |
| MDR Report Key | 9904241 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date Facility Aware | 2020-03-30 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OT VERIO IQ METER |
| Generic Name | GLUCOSE MONITORING SYS/KIT |
| Product Code | NBW |
| Date Received | 2020-03-31 |
| Model Number | 022-275 |
| Catalog Number | 022-275 |
| Lot Number | 4571750 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFESCAN EUROPE GMBH |
| Manufacturer Address | GUBELSTRASSE 34 ZUG 6300 CH 6300 |
| Product Code | --- |
| Date Received | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-31 |