FDA Adverse Event
Other
Summary report: N
BGSTAR BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 2492420
·
Received March 12, 2012
Report
- Report Number
- 3004637226-2012-00001
- Event Type
- Other
- Date Received
- March 12, 2012
- Date of Event
- May 10, 2011
- Report Date
- March 8, 2012
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- PMA / PMN Number
- K072413
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY AGAMATRIX, INC. ON (B)(4) 2011, WITH THE FOLLOWING FINDINGS: THE METER WAS WORKING PROPERLY. IF AGAMATRIX RECEIVES ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, AGAMATRIX CONSIDERS THIS CASE CLOSED.
Description of Event or Problem · 1
PATIENT STATED BGSTAR SHOWED HIGH READINGS COMPARED TO LAB OVER SEVERAL DAYS. ONE DAY PATIENT HAD A READING OF 5.4 MMOL/L AND LATER DEVELOPED HYPOGLYCAEMIA. THE PATIENT WAS TREATED AT THE DOCTOR'S OFFICE WITH GLUCOSE AND REMAINED UNDER MEDICAL OBSERVATION FOR ONE HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BGSTAR BLOOD GLUCOSE MONITORING SYSTEM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | AGAMATRIX, INC. | 8000-05000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |