MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for CONTOUR NEXT 7314 manufactured by Ascensia Diabetes Care Us Inc..
[186093780]
The patient/family was the initial reporter, so personal information was not entered. No information was captured as the customer's weight was not provided.
Patient Sequence No: 1, Text Type: N, H10
[186093781]
The customer reported that she performed a control test at 3:27 a. M. And obtained a reading of 217 mg/dl on the contour next one meter. The meter did not automatically mark it as a control test, and so the reading will be displayed as a blood result when accessing the meter's memory. There was no allegation of an adverse event. The customer was advised to return the device for evaluation. A replacement meter kit was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00149 |
| MDR Report Key | 9865721 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHWETA GULATI |
| Manufacturer Street | 100 SUMMIT LAKE DRIVE |
| Manufacturer City | VALHALLA, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 2361830 |
| Manufacturer G1 | BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL |
| Manufacturer Street | REGISTRATION NUMBER: 1220649 7 JACKSON RD. |
| Manufacturer City | DEVENS, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR NEXT |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJX |
| Date Received | 2020-03-23 |
| Model Number | 7314 |
| Catalog Number | 7314 |
| Lot Number | 9BV2G52 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
| Manufacturer Address | 100 SUMMIT LAKE DRIVE VALHALLA, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |