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 DIAGNOSTICS GMBH |
sandhoferstrasse 116 |
na |
mannheim 68305 |
GM
68305
|
|
Manufacturer Contact |
greg
smith
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 11423893 |
MDR Text Key | 239147195 |
Report Number | 3011393376-2021-00748 |
Device Sequence Number | 1 |
Product Code |
LZG
|
Combination Product (y/n) | N |
Reporter Country Code | RS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/03/2021 |
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 Catalogue Number | 06764991001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/25/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/04/2021 |
Initial Date FDA Received | 03/05/2021 |
Supplement Dates Manufacturer Received | 06/02/2021
|
Supplement Dates FDA Received | 06/03/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
Patient Age | 9 YR |
Patient Weight | 37 |
|
|