BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2202839 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05800
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP AND CARTRIDGE HAVE NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICES ARE 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) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT INDICATED THAT THE ELEVATED BG LEVELS BEGAN ON (B)(6), 2011, AT AROUND 12:00 AM. HER BG LEVEL WAS IN THE "400 MG/DL" RANGE. AT 10:00 AM THAT SAME DAY, THE PATIENT CHANGED THE CARTRIDGE, SITE, AND SET. AFTER CHANGING THE SUPPLIES AND SITE, THE PATIENT REPORTEDLY NOTICED INSULIN LEAKING AT THE LUER LOCK CONNECTION WHEN SHE ATTEMPTED TO DELIVER A BOLUS. TROUBLESHOOTING REVEALED THAT THE PATIENT DID NOT COMPLETE THE CANNULA FILL AT THAT TIME PER A REVIEW OF THE PRIME HISTORY. AT 11:00 AM THAT SAME MORNING, THE PATIENT REPORTEDLY WENT TO AN EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE CCU WITH A DIAGNOSIS OF DKA. THE PATIENT'S BG LEVEL WAS REPORTEDLY IN THE "500 MG/DL" RANGE. THE PATIENT WAS REMOVED FROM THE PUMP AND PLACED ON AN INSULIN DRIP. SUBSEQUENTLY, THE INSULIN DRIP WAS DISCONTINUED DURING THE TIME OF CONCERN AND THE PATIENT WAS PLACED IN SLIDING-SCALE HUMALOG INSULIN. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE FOUND A CARTRIDGE TO BE POSSIBLY LEAKING AND SHE WAS HOSPITALIZED FOR DKA.

    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 19 YR Hospitalization| L| R