FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PROFILE
MDR report key: 423488
·
Received May 20, 2002
Report
- Report Number
- 2939301-2002-06310
- Event Type
- Malfunction
- Date Received
- May 20, 2002
- Report Date
- May 12, 2002
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PT REPORTED EXPERIENCING INACCURATE HIGH RESULTS WITH A ONE TOUCH PROFILE METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 330, 250, 229 AND 167MG/DL. TESTS WERE DONE WITHIN 10 MINS. PT IS USING EXPIRED CONTROL SOLUTION FOR TESTS. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.
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 | 51 YR |