FDA Adverse Event
Injury
Summary report: N
CONTOUR NEXT
MDR report key: 3812183
·
Received May 15, 2014
Report
- Report Number
- 1826988-2014-00178
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 30, 2014
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K111268
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 134MG/DL ON THE CONTOUR NEXT EZ METER BUT WAS SYMPTOMATIC FOR HYPOGLYCEMIA: WEAK AND SWEATING. SHE WAS TAKEN TO THE HOSPITAL AND RETESTED WITH THEIR MONITORING SYSTEM THE READING WAS 45MG/DL. SHE WAS TREATED INTRAVENOUSLY AND LATER RELEASED FROM THE HOSPITAL. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. REPLACEMENT METER AND STRIPS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291898 | CONTOUR NEXT | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE LLC | 7310 | 4AFEC31 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |