BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2100524 · Received May 24, 2011

    Report

    Report Number
    2531779-2011-03645
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. NO POWER ISSUES WERE OBSERVED IN THE PUMP HISTORY. THE PUMP HISTORY SHOWED THE PUMP RETURNING TO DEFAULT TIME AND DATE. NO DAMAGE WAS FOUND TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE PUMP WAS EXERCISED FOR 24 HRS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP WAS LEFT WITHOUT POWER FOR FIVE MINUTES. WHEN THE PUMP WAS POWERED ON IT HAD RETURNED TO THE DEFAULT TIME AND DATE. IN ORDER TO RESUME THE PUMP, THE USER MUST CONFIRM THE CORRECT TIME, DATE AND BATTERY SETTINGS ON THE VERIFY SCREEN. THE PUMP WAS OPENED AND THE INTERNAL BATTERY ((B)(4)) WAS FOUND TO HAVE FAILED; NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT (B)(6) SHE EXPERIENCED BLOOD GLUCOSE (BG) ABOUT 40MG/DL WITH UNRESPONSIVENESS. SHE WAS TREATED WITH GLUCAGON. HER BG RESOLVED TO 189MG/DL. SHE STATED SHE NOTICED AFTER THE EVENT THAT THE TIME WAS INCORRECT AND SHE HAD RECEIVED THE WRONG BASAL RATE DELIVERY. SHE CONTINUED TO USE THE PUMP AND CORRECTED THE TIME ON SEVERAL OCCASIONS. THE PATIENT THEN REPORTED THAT ON (B)(6) 2011 HER BG LEVEL WAS 50MG/DL WITH SHAKINESS AND CONFUSION. HER ROOMMATE TREATED HER WITH SUGAR AND HONEY AND HER BG RESOLVED TO 108MG/DL. SHE REPORTED THAT THE PUMP TIME WAS INCORRECT AND THEREFORE SHE RECEIVED THE WRONG BASAL RATE DELIVERY. THE PATIENT CONFIRMED THAT THE TIME AND DATE WERE CORRECT (B)(6) AND THE BATTERY HAD NOT BEEN REMOVED. SHE STATED THAT AFTER THE INCIDENT SHE CORRECTED THE TIME AND DATE. AT THE TIME OF THE CALL SHE CONFIRMED THAT THE TIME AND DATE ARE CORRECT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening