Brand Name | ACCU-CHEK ® AVIVA PLUS TEST STRIPS |
Type of Device | BLOOD GLUCOSE MONITORING TEST STRIPS |
Manufacturer (Section D) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
indianapolis IN 46250 0457 |
|
Manufacturer (Section G) |
ROCHE DIABETES CARE, INC. |
9115 hague road |
na |
indianapolis IN 46250 1025 |
|
Manufacturer Contact |
greg
smith
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 7646449 |
MDR Text Key | 112892264 |
Report Number | 3011393376-2018-02729 |
Device Sequence Number | 1 |
Product Code |
NBW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101299 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Patient Family Member or Friend
|
Type of Report
| Initial,Followup |
Report Date |
09/18/2018 |
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 |
Patient Family Member or Friend
|
Device Catalogue Number | 06908217001 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/06/2018
|
Initial Date FDA Received | 06/28/2018 |
Supplement Dates Manufacturer Received | 09/04/2018
|
Supplement Dates FDA Received | 09/18/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 86 YR |
Patient Weight | 64 |