MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-07 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..
[183480817]
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. Since the product was discarded, the product information could not be obtained. Therefore, no information was captured (model #, lot # and expiration date) and device manufacture date could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[183480818]
The customer reported that he performed control tests on the contour next link meter and obtained readings of 102 mg/dl and 201 mg/dl. The meter did not automatically mark them as control tests, and so the readings will be displayed as blood results when accessing the meter's memory. The customer stated that the reading of 102 mg/dl was transferred to the insulin pump. The customer did not accept the insulin bolus suggested by the insulin pump based on the control reading of 102 mg/dl. There was no allegation of an adverse event. The customer disposed the control solution involved in the event. A replacement meter kit was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00079 |
| MDR Report Key | 9680734 |
| Report Source | CONSUMER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-07 |
| Returned To Mfg | 2020-03-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-02-07 |