Brand Name | ACCU-CHEK ® INSIGHT RAPIDLINK 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) |
FRESENIUS KABI DEUTSCHLAND GMBH |
robert-koch-strasse 5 |
na |
bad hersfeld D-362 51 |
GM
D-36251
|
|
Manufacturer Contact |
john
krug
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 13804114 |
MDR Text Key | 287392702 |
Report Number | 3011393376-2022-00835 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/15/2022 |
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 | 32143120 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/08/2022 |
Initial Date FDA Received | 03/18/2022 |
Supplement Dates Manufacturer Received | 06/13/2022
|
Supplement Dates FDA Received | 06/15/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Treatment | LIBRE 2 SYSTEM |
Patient Age | 55 YR |
Patient Sex | Female |