MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-31 for ACCU-CHEK ? CONNECT APP 07250452001 manufactured by Roche Diabetes Care, Inc..
[98748468]
It was unknown if the initial reporter sent a report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[98748469]
Caller reported the app is no longer taking into account her blood glucose, only recommending a carb bolus. No adverse event reported. Requested return of back up file for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[110586066]
Using a retention phone and demonstration code, the investigative unit applied the customer's settings in order to attempt to replicate the customer's allegation. No issues were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011393376-2018-00484 |
| MDR Report Key | 7231493 |
| Report Source | CONSUMER |
| Date Received | 2018-01-31 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-05-21 |
| Date Added to Maude | 2018-01-31 |
| 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 | PATIENT |
| 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 | 2018-01-31 |
| Catalog Number | 07250452001 |
| Lot Number | 2.1.3.3 |
| ID Number | NA |
| 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 | 2018-01-31 |