FDA Adverse Event
Injury
Summary report: N
CONTROL BLOOD GLUCOSE METER
MDR report key: 905998
·
Received August 29, 2007
Report
- Report Number
- MW5003587
- Event Type
- Injury
- Date Received
- August 29, 2007
- Report Date
- August 29, 2007
- Manufacturer
- U.S. DIAGNOSTIC, INC.
- Product Code
- NBW
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER WAS GIVING WRONG READING. IN THE MORNING OF 8/27, METER READING WAS 219, EVENING WAS 59, MORNING OF 8/28, 44 & 62. PATIENT ALSO USE QUALITY ONE TOUCH FROM J & J. ONE TOUCH WILL READ 158 TO 59, 229 TO 49 AND 314 TO 62. METER IS NOT RELIABLE, FDA NEEDS TO INVESTIGATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTROL BLOOD GLUCOSE METER | NONE | NBW | U.S. DIAGNOSTIC, INC. | IMG0002G3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |