FDA Adverse Event
Other
Summary report: N
ELITE 4 DATE CANADA
MDR report key: 730926
·
Received June 6, 2006
Report
- Report Number
- 1826988-2006-00644
- Event Type
- Other
- Date Received
- June 6, 2006
- Date of Event
- May 19, 2006
- Report Date
- May 19, 2006
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER PURCHASED CANADIAN METER AT U.S. RETAILER.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE METER HAD BEEN GIVING READINGS OF 50 AND 42. WHILE TROUBLESHOOTING, IT WAS DISCOVERED THE METER WAS CANADIAN, AND WAS SET IN MMOL/L. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS DUE TO THE MMOL/L READINGS. THE CUSTOMER WAS GOING TO DISPOSE OF THE METER, AND A REPLACEMENT ELITE XL WAS TO BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE 4 DATE CANADA | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 3888 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |