FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH BASIC ENHANCED
MDR report key: 465279
·
Received June 6, 2003
Report
- Report Number
- 2939301-2003-03852
- Event Type
- Malfunction
- Date Received
- June 6, 2003
- Report Date
- May 29, 2003
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PT CALLED LFS ON 5/29/2003 ALLEGING THEIR METER WAS MISSING SEGMENTS. PT REPORTED SYMPTOM OF DIZZINESS WHILE ATTEMPTING TO USE THE METER. PT DID NOT RECIEVE ANY MEDICAL ATTENTION, NOR DID PT ALLEGE HARM. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. PT ALSO REPORTED BLOOD GLUCOSE RESULTS OF 251, 166, AND 194 MG/DL WITH THE SAME LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH BASIC ENHANCED | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |