FDA Adverse Event
Injury
Summary report: N
CONTOUR
MDR report key: 1673773
·
Received April 30, 2010
Report
- Report Number
- 1826988-2010-00296
- Event Type
- Injury
- Date Received
- April 30, 2010
- Date of Event
- April 1, 2010
- Report Date
- April 1, 2010
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE 510 (K) # OF THIS SYSTEM HAS BEEN WITHDRAWN AT THE REQUEST OF THE FDA. THE 510(K) NUMBER WAS K023657.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE WAS RECEIVING LOW BLOOD GLUCOSE READINGS OF 64 MG/DL USING HER CONTOUR METER. ON ONE OCCASION, SHE RECEIVED A READING OF 64 MG/DL AND CALLED PARAMEDICS BECAUSE, SHE WAS UNABLE TO GET OUT OF BED. THE CUSTOMER WAS UNABLE TO PROVIDE THE GLUCOSE READINGS THAT PARAMEDICS RECEIVED, BUT SHE WAS TREATED WITH IV GLUCOSE BEFORE SHE WAS TAKEN TO THE HOSPITAL. WHILE TROUBLESHOOTING, IT WAS DISCOVERED THE CUSTOMER WAS USING EXPIRED TEST STRIPS. NO PRODUCT WILL BE RETURNED. A NEW CONTOUR METER KIT WAS SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 7151 | 5JB3A06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |