MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-31 for OT VERIO TEST STRIP manufactured by Lifescan Europe Gmbh.
[177147773]
On (b)(6) 2019, the reporter contacted lifescan (b)(4), alleging a strip cut issue with their onetouch verio test strips. There was no indication that the product caused or contributed to an adverse event. The lay user/patient? S test strips have been returned and evaluated with the following findings: the test strips failed testing. The reported issue was confirmed; the test strips were found to have been mis-cut during the slitting and vialling process at the time of manufacture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008382007-2020-03853 |
| MDR Report Key | 9652736 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SIMON PALMER |
| Manufacturer Street | BEECHWOOD PARK NORTH |
| Manufacturer City | INVERNESS IV2 3ED |
| Manufacturer Country | GB |
| Manufacturer Postal | IV2 3ED |
| Manufacturer Phone | 1463383679 |
| Manufacturer G1 | LIFESCAN SCOTLAND |
| Manufacturer Street | BEECHWOOD PARK NORTH |
| Manufacturer City | INVERNESS IV2 3ED |
| Manufacturer Country | GB |
| Manufacturer Postal Code | IV2 3ED |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OT VERIO TEST STRIP |
| Generic Name | GLUCOSE MONITORING SYS/KIT |
| Product Code | CGA |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-01-09 |
| Lot Number | 4288571 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFESCAN EUROPE GMBH |
| Manufacturer Address | GUBELSTRASSE 34 ZUG 6300 CH 6300 |
| Product Code | --- |
| Date Received | 2020-01-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |