FDA Adverse Event
Other
Summary report: N
ONE TOUCH BASIC
MDR report key: 389750
·
Received March 18, 2002
Report
- Report Number
- 2939301-2002-03585
- Event Type
- Other
- Date Received
- March 18, 2002
- Report Date
- February 15, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PT CALLED ALLEGING THAT ONE TOUCH BASIC METER WAS GIVING INACCURATELY LOW READINGS. PT REPORTED HAVING SYMPTOMS OF HIGH BLOOD GLUCOSE. PT GOT READING OF 45MG/DL. PT ATE 4 SCOOPS OF JELLY TO RAISE LEVELS AND RETESTED AGAIN WITH A RESULT OF 51MG/DL. PT WENT TO THE EMERGENCY ROOM WHICH IS RIGHT ACROSS THE STREET AND PT'S LEVELS TURNED OUT TO BE 345MG/DL. IT WAS FOUND THE METER AND STRIP CODES DID NOT MATCH. NO FURTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH BASIC | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization |