FDA Adverse Event
Injury
Summary report: N
ONE TOUCH ULTRA
MDR report key: 486853
·
Received October 1, 2003
Report
- Report Number
- 2939301-2003-07317
- Event Type
- Injury
- Date Received
- October 1, 2003
- Report Date
- September 21, 2003
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PT WENT TO THE HOSPITAL (NOT RELATED TO THE METER) AND THE METER WAS FUNCTIONING. THE MORNING AFTER COMING HOME FROM THE HOSPITAL PT ATTEMPTED TO TEST BUT THE METER WOULD NOT POWER ON. PT FELT HIGH, PT WAS SWEATING AND EXPERIENCING FREQUENT URINATION. PT HOME HEALTH RN ARRIVED AND TESTED THE BLOOD SUGAR AND OBTAINED A RESULT OF 441 MG/DL ON HER METER. THE PT WAS GIVEN 10 UNITS OF REGULAR INSULIN ALONG WITH THE 50 UNITS OF THE LONG-ACTING INSULIN. THE ISSUE WITH THE METER WAS UNRESOLVED. PT HAS RECEIVED THE NEW METER AS OF 09/24/2003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | GLUCOSE MONITORING SYS/KIT | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Life Threatening| R |