Brand Name | ACCU-CHEK AVIVA |
Type of Device | BLOOD GLUCOSE MONITORING DEVICE |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
SANMINA-SCI CORPORATION |
rathealy road |
na |
fermoy 00000 |
EI
00000
|
|
Manufacturer Contact |
greg
smith
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 10816261 |
MDR Text Key | 215497893 |
Report Number | 3011393376-2020-04060 |
Device Sequence Number | 1 |
Product Code |
NBW
|
UDI-Device Identifier | 00365702544109 |
UDI-Public | 00365702544109 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043474 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/14/2020 |
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 |
Other
|
Device Model Number | 06870287001 |
Device Catalogue Number | 06870287001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/30/2020 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/09/2020 |
Initial Date FDA Received | 11/10/2020 |
Supplement Dates Manufacturer Received | 12/07/2020
|
Supplement Dates FDA Received | 12/15/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
|
|