BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 881439 · Received July 16, 2007

    Report

    Report Number
    3004637226-2007-00003
    Event Type
    Other
    Date Received
    July 16, 2007
    Date of Event
    May 19, 2006
    Report Date
    July 13, 2007
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL FOLLOW-UP CALL TO THE CUSTOMER IN 2006 PROVIDED A REPLACEMENT OF A PRIOR USE MANUFACTURER. THE METER WAS RETURNED TO THE DISTRIBUTOR AND WAS FORWARDED TO AGAMATRIX FOR EVALUATION. WHEN DISTRIBUTOR RECEIVED THE METER FROM THE CUSTOMER, THE LAST READING SHOWING WAS 309. THIS DOES NOT CONFIRM THE ACTUAL READING TAKEN FOR SELF-MONITORING AT THE TIME OF THE INCIDENT. DISTRIBUTOR FOLLOW-UP ACTION: 2006 - SHIPPED CUSTOMER A NO-CHARGE REPLACEMENT METER; 2006 - DISTRIBUTOR RECEIVED RETURNED METER; 2006 - CUSTOMER CANCELLED HER ACCOUNT.

    Description of Event or Problem · 1

    CUSTOMER CALLED DISTRIBUTOR'S CUSTOMER SERVICE AND LEFT A VOICEMAIL MESSAGE STATING THAT SHE FELT HER METER WAS READING TOO HIGH AND THAT IT "NEARLY KILLED HER." SHE HAD TAKEN A READING, CLAIMING THAT IT WAS HIGH, SO SHE MEDICATED HERSELF AND WAS RUSHED TO THE HOSPITAL AS A RESULT OF LOW BLOOD SUGAR. IT IS NOT CLEAR WHAT THE USER'S READING WAS AT THE TIME OF DOSAGE AND WHAT SHE WAS MEDICATING HERSELF WITH OR WHAT THE DOSE WAS. THE RESULTS OF THE TRIP TO THE HOSPITAL ALSO HAVE NOT BEEN REVEALED OR WHAT THE TREATMENT, IF ANY, WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM BGMS NGW AGAMATRIX, INC. 8000-0067

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization