FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PROFILE
MDR report key: 447244
·
Received March 7, 2003
Report
- Report Number
- 2939301-2003-01790
- Event Type
- Malfunction
- Date Received
- March 7, 2003
- Report Date
- March 4, 2003
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
MEDICAL AFFAIRS WAS UNABLE TO GET A HOLD OF PT AND WILL BE SENDING PT A LETTER. PT HAD A REACTION OVERNIGHT AFTER THE READING WAS 119MG/DL AND THE PARAMEDICS WERE CALLED. NO OTHER INFO ABOUT THAT INCIDENT WAS DOCUMENTED. THE PT ALSO REPORTED BLOOD GLUCOSE RESULTS OF 128, 148, 167, 121, 159, AND 119MG/DL WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/OR <=20MG/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 PROFILE | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CFR | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |