FREESTYLE FREEDOM
Report
- Report Number
- 2954323-2017-00509
- Event Type
- Malfunction
- Date Received
- January 18, 2017
- Date of Event
- January 9, 2017
- Report Date
- April 3, 2019
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- NBW
- PMA / PMN Number
- K092638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
UNLESS FURTHER INFORMATION IS OBTAINED, THIS ISSUE IS CONSIDERED CLOSED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THIS SERVES AS A CORRECTION REPORT. BRAND NAME WAS INCORRECTLY IDENTIFIED AS FREESTYLE FREEDOM 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 K092638, AND CATALOG NO# HAS BEEN UPDATED TO 11001-02.
THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. A NEW ISSUE WAS OBSERVED. UPON VISUAL INSPECTION, DAMAGE TO THE TOP HOUSING OF THE METER WAS OBSERVED. THE METER POWERED ON WITH BUTTON DEPRESSION AND WITH STRIP INSERTION. A BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS SERVES AS A CORRECTION REPORT. (DATE RECEIVED BY MFG) WAS INCORRECTLY DOCUMENTED IN FOLLOW-UP REPORT #2. THE CORRECT DATE IS DECEMBER 11,2018.
THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. A NEW ISSUE WAS OBSERVED. UPON VISUAL INSPECTION, DAMAGE TO THE TOP HOUSING OF THE METER WAS OBSERVED. THE METER POWERED ON WITH BUTTON DEPRESSION AND WITH STRIP INSERTION. A BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS SERVES AS A CORRECTION REPORT. DATE OF EVENT WAS INCORRECTLY DOCUMENTED IN FOLLOW-UP REPORT #2. THE CORRECT DATE IS (B)(6) 2017.
THIS SERVES AS A CORRECTION REPORT. THE DATE REC'D BY MFR DATE AND FOLLOW-UP REPORT # WERE DOCUMENTED INCORRECTLY IN FOLLOW-UP #4. FOLLOW-UP #4 SHOULD HAVE REFERENCED FOLLOW-UP # 3, NOT 2, AND THE CORRECT DATE REC'D BY MFR DATE FOR FOLLOW-UP #3 SHOULD HAVE BEEN DOCUMENTED AS NOVEMBER 6, 2018.
THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. A NEW ISSUE WAS OBSERVED. UPON VISUAL INSPECTION, DAMAGE TO THE TOP HOUSING OF THE METER WAS OBSERVED. THE METER POWERED ON WITH BUTTON DEPRESSION AND WITH STRIP INSERTION. A BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT IS NOT CONFIRMED.
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.
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.
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.
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.
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 |
|---|---|---|---|---|---|---|---|
| 43191 | FREESTYLE FREEDOM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC. | 11001-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |