FDA Adverse Event
Other
Summary report: N
ONE TOUCH ULTRA
MDR report key: 375764
·
Received January 30, 2002
Report
- Report Number
- 2939301-2002-00997
- Event Type
- Other
- Date Received
- January 30, 2002
- Report Date
- October 5, 2001
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
METER NAME: ONE TOUCH ULTRA, STRIP NAME: LIFESCAN OT ULTRA, METER CODE: UNK. STRIP CODE: UNK. STRIP STORAGE: UNK. SYMPTOMS ARE: NONE. A PT REPORTED THAT THEIR MEDICATION WAS CHANGED DUE TO LOW READINGS ON METER. CUSTOMER WAS UNAWARE THAT THEIR METER WAS SET IN MMOL/L. PT'S METER ALLEGEDLY HAD AN APPLY SAMPLE MESSAGE. THE RESULT ON THEIR METER WAS 5.2MMOL. THE RESULT ON THE ER METER WAS 171MG/DL. THE TIME DIFFERENCE BETWEEN PT'S METER AND ER METER WAS 3 HRS. CUSTOMER DID NOT RECEIVE ANY TREATMENT. BUT SINCE PT'S 5.2MMOL/L READING WAS INTERPRETED AS 52MG/DL, PT'S MEDICATION DOSAGE WAS CHANGED. NO FURTHER INFO 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 | 63 YR | Hospitalization |