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 | 12216094 |
MDR Text Key | 263106030 |
Report Number | 3011393376-2021-02234 |
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 |
Report Date |
08/16/2021 |
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 Lot Number | ASKU |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/20/2021 |
Initial Date Manufacturer Received |
07/15/2021 |
Initial Date FDA Received | 07/23/2021 |
Supplement Dates Manufacturer Received | 08/13/2021
|
Supplement Dates FDA Received | 08/16/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Age | 54 YR |
Patient Weight | 68 |
|
|