FDA Adverse Event
Malfunction
Summary report: N
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 2493367
·
Received March 12, 2012
Report
- Report Number
- 3004637226-2012-00002
- Event Type
- Malfunction
- Date Received
- March 12, 2012
- Date of Event
- January 18, 2012
- Report Date
- March 8, 2012
- Manufacturer
- AGAMATRIX
- Product Code
- NBW
- PMA / PMN Number
- K103544
- Product Problem
- 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 (B)(4) 2012 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 COMPLAINING THAT THE IBGSTAR READINGS ARE NOT AS ACCURATE AS THEY ARE ON HIS PREVIOUS BGM APPROXIMATELY 8 MMOL/L ON PREVIOUS BGM AND AROUND 16 MMOL/L ON IBGSTAR. PATIENT CLAIMS A LOT OF HIS READINGS ARE AROUND TWICE AS MUCH AS THEY ARE SUPPOSED TO BE AND THAT HE IS SUFFERING FROM HYPOS BECAUSE OF THIS, AS HE IS INCREASING HIS DOSAGE BASED ON THE READINGS FROM HIS METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | AGAMATRIX | 8000-06961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |