Brand Name | ACCU-CHEK INSIGHT FLEX |
Type of Device | SUBCUTANEOUS INFUSION SET |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
MDR Report Key | 11079178 |
MDR Text Key | 224027337 |
Report Number | 3011393376-2020-04646 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
03/23/2021 |
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 Expiration Date | 04/08/2022 |
Device Catalogue Number | 00048011812 |
Device Lot Number | 1295787 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/22/2021 |
Initial Date Manufacturer Received |
12/24/2020
|
Initial Date FDA Received | 12/28/2020 |
Supplement Dates Manufacturer Received | 02/01/2021 02/24/2021
|
Supplement Dates FDA Received | 02/10/2021 03/23/2021
|
Patient Sequence Number | 1 |
Treatment | UNKNOWN INSULIN |
Patient Age | 68 YR |
|
|