FDA Adverse Event
Injury
Summary report: N
CONTOUR NEXT
MDR report key: 7050543
·
Received November 21, 2017
Report
- Report Number
- 1826988-2017-00348
- Event Type
- Injury
- Date Received
- November 21, 2017
- Date of Event
- October 27, 2017
- Report Date
- October 27, 2017
- Manufacturer
- ASCENSIA DIABETES CARE US INC
- Product Code
- NBW
- PMA / PMN Number
- K121190
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED.
Description of Event or Problem · 1
A (B)(6) CUSTOMER WAS FEELING DIZZY, SO RAN A BLOOD GLUCOSE TEST ON THE CONTOUR NEXT. THE RESULT WAS 16.5MMOL/L. HE RETESTED ON THE METER AND RECEIVED A SECOND READING OF 2.8MMOL/L. HE DID NOT TAKE ANY ACTION BASED ON EITHER READING. THE STRIPS WERE NOT EXPECTED TO BE RETURNED. A NEW METER AND STRIPS WERE SENT TO HIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 827743 | CONTOUR NEXT | BLOOD GLUOCSE TEST STRIPS | NBW | ASCENSIA DIABETES CARE US INC | 7321 | 6MPEF03A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |