MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-26 for OT ULTRA TEST STRIPS manufactured by Lifescan Europe Gmbh.
| Report Number | 3008382007-2019-03515 |
| MDR Report Key | 8929425 |
| Report Source | CONSUMER |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-01 |
| Date Mfgr Received | 2019-08-01 |
| Date Added to Maude | 2019-08-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | OYINKAN DONALDSON |
| Manufacturer Street | GUBELSTRASSE 34 |
| Manufacturer City | ZUG 6300 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6300 |
| Manufacturer G1 | LIFESCAN EUROPE GMBH |
| Manufacturer Street | GUBELSTRASSE 34 |
| Manufacturer City | ZUG 6300 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OT ULTRA TEST STRIPS |
| Generic Name | GLUCOSE MONITORING SYS/KIT |
| Product Code | CGA |
| Date Received | 2019-08-26 |
| Returned To Mfg | 2019-04-19 |
| Lot Number | 4369481 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFESCAN EUROPE GMBH |
| Manufacturer Address | GUBELSTRASSE 34 ZUG 6300 SZ 6300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-26 |