FDA Adverse Event
Injury
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1020668
·
Received March 27, 2008
Report
- Report Number
- 1826988-2008-00311
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE TESTED HER GLUCOSE AND RECEIVE A HIGH READING OF 262 MG/DL USING HER CONTOUR METER. SHE TOOK INSULIN BASED ON THE READING. THE NEXT MORNING, PARAMEDICS WERE CALLED BECAUSE THE CUSTOMER'S GLUCOSE DROPPED TOO LOW AND SHE WAS CONFUSED. PARAMEDICS TESTED THE CUSTOMER'S GLUCOSE AT 29 MG/DL USING THEIR METER. THE CUSTOMER WAS TREATED WITH I.V. GLUCOSE AND GIVEN FOOD. PARAMEDICS LEFT ONCE THE CUSTOMER'S GLUCOSE WAS AT 86 MG/DL. TROUBLESHOOTING SHOWED THE METER TO BE OPERATING AS DESIGNED. THE TEST STRIPS AND METER WERE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR TEST STRIPS (50) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | NOT PROVIDED | 7DC3B03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |