Brand Name | ACCU-CHEK ® SPIRIT COMBO |
Type of Device | INSULIN INFUSION PUMP |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
ROCHE DIABETES CARE GMBH |
sandhoferstrasse 116 |
na |
mannheim 68305 |
GM
68305
|
|
Manufacturer Contact |
john
krug
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 16788544 |
MDR Text Key | 313779522 |
Report Number | 3011393376-2023-00965 |
Device Sequence Number | 1 |
Product Code |
LZG
|
UDI-Device Identifier | 04015630880119 |
UDI-Public | 04015630880119 |
Combination Product (y/n) | N |
Reporter Country Code | RS |
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 |
04/21/2023 |
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 Model Number | 05027250001 |
Device Catalogue Number | 05027250001 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/14/2023 |
Initial Date FDA Received | 04/21/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
Patient Age | 16 YR |
Patient Sex | Female |
|
|