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 | 14251471 |
MDR Text Key | 290400253 |
Report Number | 3011393376-2022-01298 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
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 |
Report Date |
04/29/2022 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/01/2023 |
Device Lot Number | 5351323 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/18/2022 |
Initial Date FDA Received | 04/29/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/01/2021 |
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Treatment | UNKNOWN INSULIN PEN |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 43 YR |
Patient Sex | Male |