FDA Adverse Event
Other
Summary report: N
WAVESENSE PRESTO BGM SYSTEM
MDR report key: 1846513
·
Received September 28, 2010
Report
- Report Number
- 3004637226-2009-00005
- Event Type
- Other
- Date Received
- September 28, 2010
- Date of Event
- July 27, 2009
- Report Date
- August 21, 2009
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- PMA / PMN Number
- K073573
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TESTED TEST STRIP RETAIN (SAME LOT #) AGAINST REFERENCE (B)(4) AND SEARCHED THE COMPLAINT DATABASE TO DETERMINE OTHER COMPLAINTS ON THE TEST STRIP LOT #. YSI RESULTS: PASSED, WITHIN ACCEPTABLE READINGS. DATABASE SEARCH: PASS, NO OTHER COMPLAINTS ON THIS LOT OF TEST STRIPS.
Description of Event or Problem · 1
BLOOD SUGARS LOW, CUSTOMER WAS HOSPITALIZED DUE TO READINGS. SHE WAS PUT INTO THE HOSPITAL BECAUSE SHE GOT HER SUGAR FELL TO VERY LOW AND THE READINGS THE PRESTO METER PROVIDED WERE NOT ACCURATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVESENSE PRESTO BGM SYSTEM | PRESTO | NBW | AGAMATRIX, INC. | PRESTO STRIPS | GA17WJ83B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization |