Brand Name | ACCU-CHEK CONNECT APP |
Type of Device | DIABETES MANAGEMENT SOFTWARE |
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 | 6399080 |
MDR Text Key | 69819424 |
Report Number | 3011393376-2017-01524 |
Device Sequence Number | 1 |
Product Code |
NDC
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
06/01/2017 |
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 Lot Number | 2.1.0.5 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/07/2017 |
Initial Date FDA Received | 03/13/2017 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 05/03/2017 06/01/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | Z-1899-2017 |
Patient Sequence Number | 1 |
Patient Age | 32 YR |