BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2012589 · Received February 28, 2011

    Report

    Report Number
    2531779-2011-01212
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WOKE UP WITH A 159 MG/DL BLOOD GLUCOSE RESULT. SHE CLAIMED THAT SHE WAS BOLUSING FROM HER METER REMOTE AND THAT HER BLOOD GLUCOSE LEVELS ELEVATED: HER CURRENT BLOOD GLUCOSE RESULT AT THE TIME OF THE CALL WAS 600 MG/DL. THE PT DENIED HAVING ANY SYMPTOMS OR KETONES. THE CUSTOMER SVC REP (CSR) REVIEWED THE PUMP'S HISTORY BOLUS HISTORY AND FOUND THAT 0 UNITS OF BOLUS WERE DELIVERED ALL DAY. THE CSR DISCOVERED THAT THE PT WAS INCORRECTLY ENTERING THE BOLUS AMOUNT ON THE METER REMOTE. THE PUMP SETTINGS WERE CONFIRMED TO BE CORRECT AND THE PT CHANGED OUT THE INFUSION SITE/SET. THE PT ALSO MENTIONED RECEIVING GLUCAGON INJECTION AND IV TREATMENT BY THE PARAMEDICS FOR 25 MG/DL BLOOD GLUCOSE RESULT ON (B)(6) 2011 EVENING AS A RESULT OF MISCALCULATING HER CARBOHYDRATES: THE PT ADMITTED THAT SHE GUESSED HOW MUCH INSULIN TO TAKE BASED ON HER DINNER AND ENDED UP TAKING TOO MUCH INSULIN. THE PT WAS ADVISED TO CALL HER HEALTH CARE PROFESSIONAL REGARDING THE 600 MG/DL AND TO CLOSELY MONITOR HER BLOOD GLUCOSE RESULTS. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY SUFFERED A HYPOGLYCEMIC AND HYPERGLYCEMIC EVENTS AS A RESULT OF USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R