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 |
|
Manufacturer (Section G) |
UNOMEDICAL DEVICES S.A. DE C.V |
avenida fomento industrial lot |
parque industrial del norte |
reynosa C.P. 8873 |
MX
C.P. 88736
|
|
Manufacturer Contact |
john
krug
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 12853825 |
MDR Text Key | 281097459 |
Report Number | 3011393376-2021-03648 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
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 |
11/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/01/2022 |
Device Lot Number | 5326845 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/11/2021 |
Initial Date FDA Received | 11/22/2021 |
Supplement Dates Manufacturer Received | 11/25/2021
|
Supplement Dates FDA Received | 11/26/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Treatment | LIBRE SENSOR; SOMENTE SORO |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 4 YR |
Patient Sex | Female |