Brand Name | ACCU-CHEK GUIDE 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 | 11876810 |
MDR Text Key | 252400376 |
Report Number | 3011393376-2021-01599 |
Device Sequence Number | 1 |
Product Code |
NBW
|
UDI-Device Identifier | 00365702719101 |
UDI-Public | 00365702719101 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K160944 |
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 |
06/17/2021 |
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 Expiration Date | 11/28/2021 |
Device Model Number | 08256292001 |
Device Catalogue Number | 08256292001 |
Device Lot Number | 101829 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/14/2021 |
Initial Date FDA Received | 05/25/2021 |
Supplement Dates Manufacturer Received | 06/16/2021
|
Supplement Dates FDA Received | 06/17/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/31/2020 |
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
Patient Age | 77 YR |
Patient Weight | 86 |