MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-16 for CONTOUR NEXT manufactured by Ascensia Diabetes Care Us Inc..
[183523306]
The customer returned the suspected contour next link 2. 4 meter, contour next test strips and contour next control solution for evaluation. The returned test strips were expired. It was verified that the returned control solution had no lot number and expiration date printed on the label. Further investigation will be performed. 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. Lot # was not captured as it was missing from the label of the control solution. The model # was not provided.
Patient Sequence No: 1, Text Type: N, H10
[183523307]
An advocate from germany reported that she received a bottle of contour next control solution from the hospital without a carton, and the lot number and expiration date were missing from the label of the bottle. The advocate stated that she saw the bottle being taken out of the carton at the hospital and the expiration date on the box of the carton was printed as (b)(6) 2021. There was no allegation of an adverse event. The advocate was advised to return the device for evaluation. Replacement meter and test strips were sent to the advocate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1810909-2020-00132 |
| MDR Report Key | 9835201 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-16 |
| 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 | 2020-03-16 |
| Returned To Mfg | 2020-03-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |