MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-20 for ACCU-CHEK ? CONNECT APP 07250452001 manufactured by Roche Diabetes Care, Inc..
[117613909]
Caller alleges inaccurate bolus advice. No adverse event reported. Requested back up file and meter requested to be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[130207231]
Because the connect app is downloaded by the customer and installed on the customer's phone, it is not possible to get the actual device returned. The customer did return a back up file from their device and also returned the related blood glucose meter. Manufacturer was able to pair the meter with a retention version of the software and determine that the advice provided to the customer was correct. Manufacturer was also able to simulate results and transfer to the retention software and again all advice produced was correct.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011393376-2018-03453 |
| MDR Report Key | 7797885 |
| Report Source | CONSUMER |
| Date Received | 2018-08-20 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-08-20 |
| 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 | 2018-08-20 |
| 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 | 2018-08-20 |