MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..
[173924772]
The customer stated that she did not use clean, flat and non-absorbent surface while performing control tests. As per the contour next control solution user guide, one of the testing technique is as follows: "squeeze a small drop of solution onto a clean, nonabsorbent surface. Do not apply control solution to your fingertip or to the test strip directly from the bottle. " the patient/family was the initial reporter , so personal information was not entered. Weight was left blank as the customer's weight was not provided. The model # was not provided.
Patient Sequence No: 1, Text Type: N, H10
[173924773]
The customer reported that she ran control tests using the contour next ez meter and obtained readings of 187 mg/dl and 153 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. There was no allegation of an adverse event. The customer was advised to return the control solution for evaluation. Replacement meter kit and test strips were sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00012 |
| MDR Report Key | 9543961 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-01-03 |
| 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 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 | 2020-01-03 |
| Lot Number | 9BV2G40 |
| 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 10595 US 10595 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |