FDA Adverse Event
Injury
Summary report: N
QUICKTEK BLOOD GLUCOSE METER
MDR report key: 949193
·
Received November 15, 2007
Report
- Report Number
- 1832816-2007-00011
- Event Type
- Injury
- Date Received
- November 15, 2007
- Date of Event
- October 11, 2007
- Report Date
- October 25, 2007
- Manufacturer
- LRE
- Product Code
- NBW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION.
Description of Event or Problem · 1
CALLER INDICATED THE METER GAVE E4 ERROR AND WAS UNABLE TO CHECK HER SISTERS BLOOD SUGAR AT A CRITICAL TIME. SHE WAS HAVING A DIABETIC REACTION AND TRIED TO CHECK HER BG, BUT THE METER COULD ONLY READ AN E4. THE PARAMEDICS WERE CALLED AND CHECKED HER BG AND IT WAS 64.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKTEK BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | NBW | LRE | 330001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |