Brand Name | ONETOUCH SELECT TEST STRIPS |
Type of Device | GLUCOSE MONITORING SYS/KIT |
Manufacturer (Section D) |
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
gubelstrasse 34 |
zug, 6300 |
SZ 6300 |
|
Manufacturer (Section G) |
LIFESCAN SCOTLAND |
beechwood business park north |
|
inverness, scotland IV2 3 ED |
UK
IV2 3ED
|
|
Manufacturer Contact |
goncalo
sousa
|
beechwood business park north |
inverness, scotland IV2 3-ED
|
UK
IV2 3ED
|
|
MDR Report Key | 7717521 |
MDR Text Key | 114936702 |
Report Number | 3008382007-2018-02060 |
Device Sequence Number | 1 |
Product Code |
NBW
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K072543 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/25/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | N/A |
Device Catalogue Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 07/01/2018 |
Initial Date Manufacturer Received |
07/01/2018 |
Initial Date FDA Received | 07/25/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |