FDA Adverse Event
Injury
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1012635
·
Received March 11, 2008
Report
- Report Number
- 1826988-2008-00263
- Event Type
- Injury
- Date Received
- March 11, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 91MG/DL. THE CUSTOMER'S WIFE WAS CONCERNED ABOUT THE READING, SO SHE TOOK HIM TO THE HOSPITAL. THE CUSTOMER'S GLUCOSE WAS TESTED AT 28MG/DL WHEN HE ARRIVED AT THE HOSPITAL. THE CUSTOMER WAS NOT SURE WHAT TYPE OF TREATMENT HE RECEIVED, BUT MOST LIKELY, IT WAS GLUCOSE. THE TEST STRIPS AND METER ARE TO BE 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 | 7BC3D01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |