FDA Adverse Event
Other
Summary report: N
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 881436
·
Received July 16, 2007
Report
- Report Number
- 3004637226-2007-00004
- Event Type
- Other
- Date Received
- July 16, 2007
- Date of Event
- June 14, 2007
- Report Date
- July 13, 2007
- Manufacturer
- AGAMATRIX, INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AGAMATRIX CONTACTED DISTRIBUTOR ON 27 JUN 2007. NO CONTACT HAD BEEN MADE TO CUSTOMER FROM DISTRIBUTOR. DISTRIBUTOR HAD NO RECORD OF RECEIVING LETTERS FROM CUSTOMER. CUSTOMER HAD BEEN SENDING LETTERS TO BANK LOCK BOX AND NOT CUSTOMER SERVICE.
Description of Event or Problem · 1
CUSTOMER WAS GETTING FLUCTUATING READINGS WITHIN MINS FROM EACH ONE. SENT TWO LETTERS TO DISTRIBUTOR BUT REC'D NO REPLY. A SECOND METER WAS SENT TO CUSTOMER THROUGH A SALES CALL. CUSTOMER WAS USING NEW METER FOR ABOUT ONE MONTH AND STARTED GETTING FLUCTUATED READINGS AGAIN. CUSTOMER SENT LETTER TO MFR WITH COPIES TO FDA AND DISTRIBUTOR.
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 |