FDA Adverse Event
Other
Summary report: N
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 881442
·
Received July 16, 2007
Report
- Report Number
- 3004637226-2007-00002
- Event Type
- Other
- Date Received
- July 16, 2007
- Date of Event
- May 24, 2006
- Report Date
- July 13, 2007
- Manufacturer
- AGAMATRIX INC.
- Product Code
- NBW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METER WAS RETURNED TO AGAMATRIX FOR FURTHER EVALUATION. UPON INSPECTION, THE METER WAS TESTED WITH CONTROL SOLUTION AND RETURNED EXPECTED RESULTS.
Description of Event or Problem · 1
METER READING HIGH. CUSTOMER WAS HAVING DIABETIC SYMPTOMS AND WAS USING THE METER AS INSTRUCTED. WITH THE RESULTS BEING HIGH, "OVER 600 MG", HE CALLED THE EMT (METER IS NOT EXPECTED OR DESIGNED TO READ OVER 600). EMT COMPARED RESULTS TO ANOTHER METER WHICH GAVE MEASURED 358. THE PT PERFORMED A CONTROL SOLUTION TEST WITH DISTRIBUTOR CUSTOMER SUPPORT AND RESULT WAS WITHIN ACCEPTABLE RANGE. NOT ENOUGH INFORMATION TO SUPPORT THE CALLERS' CLAIMS. DISTRIBUTOR ATTEMPTED FOLLOW UP TO THE PT BUT NO CALLS WERE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM | BGMS | NBW | AGAMATRIX INC. | 8000-0067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |