NEO METER OPTIUM FREESTYLE
Report
- Report Number
- 2954323-2022-05090
- Event Type
- Malfunction
- Date Received
- February 15, 2022
- Date of Event
- February 11, 2022
- Report Date
- August 1, 2022
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- NBW
- PMA / PMN Number
- K140371
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- 003
Narratives
AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE RETURNED METER WAS INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED METER AND NO ISSUES WERE OBSERVED. INSERTED BATTERIES BUT INDICATOR LIGHTS DID NOT FLASH. METER POWERED ON WITH BUTTON DEPRESSION. BLACK SPOTS WAS OBSERVED. DSPLGHT-2 WAS CLONED TO ADDRESS THE ISSUE. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED
AN EXTENDED INVESTIGATION HAS BEEN CONDUCTED, WHICH INVOLVED A MANUFACTURING REVIEW (INCLUDING 5 YEARS OF DEVICE HISTORY RECORDS (DHRS)), PREVIOUS COMPLAINT AND CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATIONS CONDUCTED FOR BLANK SCREEN ISSUES, PROCESS FAILURE MODE EFFECTS ANALYSES (PFMEAS), DESIGN CONTROLS, AND DESIGN FAILURE MODE EFFECTS ANALYSES (DFMEAS), RISK MANAGEMENT REPORTS, RISK EVALUATIONS, AND LABEL COPY. THE INVESTIGATION DID NOT IDENTIFY ANY INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. IF THE PRODUCT IS RETURNED, AN INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
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 |
|---|---|---|---|---|---|---|---|
| 875697 | NEO METER OPTIUM FREESTYLE | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC | 75175-84 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |