FDA Adverse Event
Other
Summary report: N
ASCENSIA ELITE BASIC
MDR report key: 638796
·
Received September 27, 2005
Report
- Report Number
- 1826988-2005-00022
- Event Type
- Other
- Date Received
- September 27, 2005
- Date of Event
- September 12, 2005
- Report Date
- September 24, 2005
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CUSTOMER CALLED STATING THAT THEIR METER IS REPORTING ERRATIC RESULTS. THEIR METER REPORTED A RESULT OF 439 MG/DL COMPARED TO THE HOSP RESULTS OF 114 MG/DL. AN EVALUATION OF THE SYSTEM WAS CONDUCTED OVER THE PHONE, WHICH DETERMINED THAT THE METER WAS WORKING WITHIN SPECIFICATIONS. SENDING OUT CONTROL SOLUTION FOR FURTHER TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA ELITE BASIC | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 3885G | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |