Brand Name | ACCU-CHEK FLEXLINK INFUSION SET |
Type of Device | SUBCUTANEOUS INFUSION SET |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
MDR Report Key | 11095368 |
MDR Text Key | 224398169 |
Report Number | 3011393376-2020-04677 |
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 |
04/12/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/30/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 08/01/2021 |
Device Catalogue Number | 04631242001 |
Device Lot Number | 5293348 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/22/2021 |
Patient Sequence Number | 1 |
Treatment | UNKNOWN INSULIN; UNKNOWN INSULIN |
Patient Age | 5 YR |
Patient Weight | 23 |
|
|