MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-15 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..
[175209518]
The patient/family was the initial reporter, so personal information was not entered. Age and weight were left blank as the customer's age and weight were not provided. The model # was not provided.
Patient Sequence No: 1, Text Type: N, H10
[175209519]
The customer from (b)(6) reported that he performed a control test and obtained a reading of 10. 9 mmol/l while using the contour next link 2. 4 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. Since the control reading was marked as blood, it was transferred to the insulin pump. There was no allegation of an adverse event. The customer was advised to return the control solution for evaluation. A replacement meter kit was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00030 |
| MDR Report Key | 9590589 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-06-01 |
| Date Added to Maude | 2020-01-15 |
| 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 NY 10595 |
| Manufacturer Country | US |
| Manufacturer Postal | 10595 |
| Manufacturer Phone | 9142361830 |
| Manufacturer G1 | BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL |
| Manufacturer Street | REGISTRATION NUMBER: 1220649 7 JACKSON RD. |
| Manufacturer City | DEVENS MA 01434 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01434 |
| 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 | 2020-01-15 |
| Lot Number | 9BV2D18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
| Manufacturer Address | 100 SUMMIT LAKE DRIVE VALHALLA NY 10595 US 10595 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |