FDA Adverse Event
Injury
Summary report: N
ONE TOUCH ULTRA
MDR report key: 389888
·
Received March 27, 2002
Report
- Report Number
- 2939301-2002-04382
- Event Type
- Injury
- Date Received
- March 27, 2002
- Report Date
- March 1, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PATIENT REPORTED THEY WERE HOSPITALIZED. THEIR METER ALLEGEDLY WAS INACCURATELY LOW. THE RESULT ON THEIR METER WAS 14.2 MMOL/L. CUSTOMER READ RESULT AS 142 MG/DL. THE RESULT OF THE LAB WAS 430 MG/DL. THE TIME DIFFERENCE BETWEEN PATIENT'S METER AND LAB WAS 10 MINUTES. TREATMENT WAS MEDICATION FOR DIABETES. CUSTOMER HAD METER SET TO WRONG UNIT OF MEASUREMENT MMOL/L. NO FURTHER INFORMATION HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| R |