BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2548484 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00009
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    December 7, 2011
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IBGSTAR METER S/N (B)(4) AND TEST STRIPS LOT #HD20WB38D, EXP. 10/2012 (RANGE 105-159MG/DL) WERE TESTED ON (B)(6) 2011. RESULTS: 147MG/DL, 145MG/DL, 140MG/DL. THE COMPLAINT COULD NOT BE CONFIRMED. THE FUNCTION TEST HAD SHOWN THAT THE IBGSTAR METER WORKED PROPERLY AND MET SPECIFICATIONS.

    Description of Event or Problem · 1

    AN EVENT OCCURRED WITH THE IBGSTAR SYSTEM WHERE INDIRECT HARM OCCURRED BECAUSE THE PATIENT INJECTED A HIGHER INSULIN DOSE AND WENT INTO HYPOGLYCEMIA BASED ON READINGS ON THE IBGSTAR WHICH WERE PRESUMED TO BE TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other