FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE LITE
MDR report key: 6142715
·
Received December 2, 2016
Report
- Report Number
- 2954323-2016-07415
- Event Type
- Malfunction
- Date Received
- December 2, 2016
- Date of Event
- November 9, 2016
- Report Date
- March 24, 2017
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- NBW
- PMA / PMN Number
- K092602
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS SERVES AS A CORRECTION REPORT. BRAND NAME WAS INCORRECTLY IDENTIFIED AS FREESTYLE LITE. THE CORRECT BRAND NAME FOR THE REPORTED METER SERIAL NUMBER IS (B)(4). BRAND NAME HAS BEEN UPDATED TO REFLECT THE CORRECTION. IN ADDITION PMA/510K# HAS BEEN UPDATED TO K092602, AND CATALOG NO# HAS BEEN UPDATED TO 71501-01.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
Description of Event or Problem · 1
THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794124 | FREESTYLE LITE | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |