BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3123829 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06860
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: PATIENT HAD PRE PUMP TRAINING LAST WEEK AND PUMP START (B)(6) 2013 IN OFFICE. AT OFFICE AGAIN ON (B)(6) 2013, THE DIABETES EDUCATOR (CDE) AND PATIENT'S GRANDMOTHER HAD TROUBLE GETTING CARTRIDGE TO FILL PROPERLY AND GO INTO PUMP. THEY EXPLAINED WHEN THEY FILL THE CARTRIDGE BEYOND 100 UNITS, INSULIN STARTS SQUIRTING OUT THE TUBING WHEN THEY SIT THE CARTRIDGE DOWN INTO THE PUMP. CDE ASKED THAT I CALL GRANDMOTHER. I JUST TALKED TO GRANDMOTHER AND PATIENT AND WALKED THROUGH ENTIRE CARTRIDGE CHANGE. I HAD GRANDMOTHER FILL CARTRIDGE WITH 200 UNITS OF INSULIN. I HAD HER GO THROUGH ALL THE CARTRIDGE CHANGE STEPS. WHEN SHE REWOUND PUMP, PUMP SCREEN READ 205 UNITS AT FULL REWIND. WHEN SHE LOADED CARTRIDGE, SHE REPORTED INSULIN SQUIRTED OUT OF THE TUBING. AFTER CARTRIDGE WAS LOADED AND LOAD CARTRIDGE STEP COMPLETED, SCREEN INDICATED CARTRIDGE ONLY HAD 135 UNITS OF INSULIN LEFT IN IT. I CANNOT DETERMINE WHAT ELSE IS WRONG WITH THE PUMP. I HAVE ASKED GRANDMOTHER TO CALL CUSTOMER SUPPORT THIS EVENING TO REVIEW STEPS WITH CUSTOMER SUPPORT TO SEE IF THEY CAN DETERMINE WHAT THE ISSUE IS. CUSTOMER TECHNICAL SUPPORT (CTS) HAS ADVISED GRANDMOTHER TO GO TO AN ALTERNATE INSULIN DELIVERY PLAN AND TO RETURN THIS PUMP. THERE IS NO ALLEGATION OF AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED AS IT WAS NOT RESOLVED IN TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225796 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR