FDA Adverse Event
Injury
Summary report: N
IBGSTAR BGMS
MDR report key: 2894246
·
Received December 27, 2012
Report
- Report Number
- 3004637226-2012-00044
- Event Type
- Injury
- Date Received
- December 27, 2012
- Date of Event
- November 1, 2012
- Report Date
- December 27, 2012
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- PMA / PMN Number
- K103544
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER MENTIONS 50 POINT INCREASE IN BLOOD GLUCOSE READINGS WHEN SHE COMPARES HER IBGSTAR METER RESULTS WITH THE FREESTYLE LIGHT. THE METER HAS BEEN MEASURING CONSISTENTLY HIGHER FOR A FEW WEEKS AND THE CALLER HAS GIVEN HERSELF INSULIN TO COMPENSATE FOR THE HIGH BLOOD SUGARS. AS A RESULT THE CALLER HAS SUFFERED FROM INSULIN REACTIONS. THE CALLER BELIEVED A VIRAL INFECTION WAS THE ROOT CAUSE OF HER INCONSISTENT BLOOD GLUCOSE READINGS, BUT CURRENTLY SUSPECTS THAT IT WAS HER METER THAT WAS PRODUCING THE HIGH RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IBGSTAR BGMS | BLOOD GLUCOSE METER | NBW | AGAMATRIX, INC. | 8000-04944 | JF03WR13H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |