Brand Name | ACCU-CHEK ® INSIGHT FLEXLINK PLUS INFUSION SET |
Type of Device | SUBCUTANEOUS INFUSION SET |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
GERRESHEIMER REGENSBURG GMBH |
hirtenstrasse 50 |
na |
pfreimd 92536 |
GM
92536
|
|
Manufacturer Contact |
greg
smith
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 7339182 |
MDR Text Key | 102398181 |
Report Number | 3011393376-2018-01161 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
05/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/21/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/15/2018 |
Initial Date FDA Received | 03/14/2018 |
Supplement Dates Manufacturer Received | 04/18/2018
|
Supplement Dates FDA Received | 05/14/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 28 YR |