MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-24 for ACCU-CHEK ? CONNECT APP 07250452001 manufactured by Roche Diabetes Care, Inc..
[124850692]
The patient alleged the bolus recommendations provided by the software application are not accurate. No adverse event reported. Software application was not requested for return, however, the back up file has been sent to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011393376-2018-04453 |
| MDR Report Key | 8000120 |
| Report Source | CONSUMER |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2018-10-24 |
| 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 |
| 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 | 2018-10-24 |
| Catalog Number | 07250452001 |
| Lot Number | 2.1.4.1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-24 |