| 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 | 8526921 |
|---|
| MDR Text Key | 142340285 |
|---|
| Report Number | 3011393376-2019-01462 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
NDC
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| PMA/PMN Number | K141929 |
|---|
| 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 |
08/20/2019 |
|---|
| 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 | 07250452001 |
|---|
| Device Lot Number | 2.1.6.3 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Initial Date Manufacturer Received |
04/10/2019 |
|---|
| Initial Date FDA Received | 04/18/2019 |
|---|
| Supplement Dates Manufacturer Received | 08/06/2019
|
|---|
| Supplement Dates FDA Received | 08/20/2019
|
|---|
| 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 |
|---|
| Treatment | UNKNOWN INSULIN |
|---|
| Patient Age | 65 YR |
|---|
| Patient Weight | 83 |
|---|
|
|
