FDA Adverse Event
Injury
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1242249
·
Received November 19, 2008
Report
- Report Number
- 1826988-2008-01372
- Event Type
- Injury
- Date Received
- November 19, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 20, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A HIGH READING USING HER CONTOUR METER. SHE TOOK INSULIN BASED ON THE READING AND HER BLOOD GLUCOSE DROPPED TO 50 MG/DL. THE CUSTOMER STATED THAT SHE WAS SYMPTOMATIC FOR HYPOGLYCEMIA WHEN SHE RECEIVED THE LOW READING. SHE WAS SHAKY AND COULD NOT SEE WELL. THE CUSTOMER PERFORMED CONTROL TESTS, WHILE TROUBLESHOOTING, AND THE RESULTS FELL WITHIN THE NORMAL CONTROL RANGE. 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 | 7080D | 8BC3C04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |