FDA Adverse Event
Malfunction
Summary report: N
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 2497409
·
Received March 11, 2012
Report
- Report Number
- 3004637226-2012-00004
- Event Type
- Malfunction
- Date Received
- March 11, 2012
- Date of Event
- January 31, 2012
- Report Date
- March 9, 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
THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY AGAMATRIX, INC. ON 02/21/2012 WITH THE FOLLOWING FINDINGS: THE METER WAS WORKING PROPERLY. IF AGAMATRIX RECEIVES ADDITIONAL INFO REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, AGAMATRIX CONSIDERS THIS CASE CLOSED.
Description of Event or Problem · 1
AFTER SEVERAL READINGS, THE METER SHOWED 300MG/DL SO THE PT INJECTED INSULIN. THEN SHE MEASURED HER BLOOD SUGAR AND THE DEVICE SHOWED 320MG/DL. THE PT WAITED 15 MINUTES AND MEASURED HER BLOOD SUGAR AGAIN, SHE HAD 350MG/DL. SO THE PT INJECTED INSULIN AGAIN AND 4 HOURS LATER SHE HAD HYPOGLYCEMIA (26MG/DL). SHE WAS HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | AGAMATRIX, INC. | 8000-05009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |