MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-28 for ACCU-CHEK ? CONNECT APP manufactured by Roche Diabetes Care, Inc..
[112715655]
The event occurred outside of the united states. While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10
[112715656]
Caller alleges her online account is showing data that is not from her devices. After deleting devices and creating a new account, uploaded results continue to show data that is not from customer's meter. Caller also alleges data shows result for tomorrow. No adverse event reported. Screenshots were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011393376-2018-02789 |
| MDR Report Key | 7649211 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-28 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA GREG SMITH |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 462500457 |
| Manufacturer Country | US |
| Manufacturer Postal | 462500457 |
| Manufacturer Phone | 3175212484 |
| Manufacturer G1 | ROCHE DIABETES CARE, INC. |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 462501025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 462501025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-CHEK ? CONNECT APP |
| Generic Name | DIABETES MANAGEMENT SOFTWARE |
| Product Code | NDC |
| Date Received | 2018-06-28 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIABETES CARE, INC. |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-28 |