Brand Name | ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE |
Type of Device | SPRING LOADED INSERTION DEVICE |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
BALDA MEDICAL GMBH & CO. KG |
bergkichener str. 228 |
na |
bad oeynhausen 32549 |
GM
32549
|
|
Manufacturer Contact |
john
krug
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 15869511 |
MDR Text Key | 304356768 |
Report Number | 3011393376-2022-03491 |
Device Sequence Number | 1 |
Product Code |
KZH
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
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,Followup |
Report Date |
04/11/2023 |
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 |
Lay User/Patient
|
Device Expiration Date | 09/01/2022 |
Device Catalogue Number | 05511097001 |
Device Lot Number | 1702 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/21/2022 |
Initial Date FDA Received | 11/28/2022 |
Supplement Dates Manufacturer Received | 01/24/2023 04/11/2023
|
Supplement Dates FDA Received | 01/25/2023 04/11/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 60 YR |
Patient Sex | Female |