Brand Name | ACCU-CHEK ® INSTANT 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 GMBH |
sandhoferstrasse 116 |
na |
mannheim 68305 |
GM
68305
|
|
Manufacturer Contact |
john
krug
|
9115 hague road |
na |
indianapolis, IN 46250-0457
|
3175212484
|
|
MDR Report Key | 19177132 |
MDR Text Key | 341183467 |
Report Number | 3011393376-2024-00904 |
Device Sequence Number | 1 |
Product Code |
CGA
|
Combination Product (y/n) | N |
Reporter Country Code | PE |
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 |
04/24/2024 |
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 | 07819366587 |
Device Lot Number | 302293 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/15/2024
|
Initial Date FDA Received | 04/24/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/03/2023 |
Is the Device Single Use? |
No
|
Patient Sequence Number | 1 |
Patient Sex | Male |