MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-18 for CONTOUR NEXT 7314 manufactured by Ascensia Diabetes Care Us Inc..
[183975396]
As per the contour next control solution instructions for use, "squeeze a small drop of solution onto a clean, nonabsorbent surface. " it was found that the customer was not using a clean, flat an non-absorbent surface. 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
[183975397]
The customer reported that he ran a control test and obtained a reading of 209 mg/dl, while using 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. Replacement meter and test strips were sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00141 |
| MDR Report Key | 9849059 |
| Report Source | CONSUMER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Model Number | 7314 |
| Catalog Number | 7314 |
| Lot Number | 8BV2G35 |
| 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 | 2020-03-18 |