FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRA
MDR report key: 615467
·
Received June 3, 2005
Report
- Report Number
- 2939301-2005-02521
- Event Type
- Malfunction
- Date Received
- June 3, 2005
- Report Date
- May 27, 2005
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE PATIENT CALLED ALLEGING ERRATIC READINGS FROM 200-168 MG/DL WITHIN 10 MINUTES FROM ONE ANOTHER. THERE IS NO INFORMATION ON WHETHER THE PATIENT EXPERIENCED ANY SYMPTOMS AT THE TIME OF TESTING. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE CONTROL SOLUTION WAS LESS THAN THE DISCARD DATE. THE PATIENT RAN SEVEN CONTROL SOLUTION TESTS PRIOR TO CONTACTING LIFESCAN AND THEY ALL FELL OUT OF RANGE EXCEPT ONE OF THE TESTS. THE METER, CONTROL SOLUTION, AND TEST STRIPS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRA | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |