BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2062661 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02503
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT ALLEGED THAT THE PUMP WAS DELIVERING AN INCORRECT DOSE OF INSULIN. ON (B)(6) 2011, AT APPROX 3:30PM, WHILE ON A CRUISE, THE PT REPORTED THAT HE HEARD BEEPS COMING FROM HIS PUMP. WHEN HE LOOKED AT THE PUMP'S SCREEN, THE PT CLAIMED IT SAID ZERO UNITS; HOWEVER, HE FELT STINGING AT THE SITE AS IF INSULIN WAS BEING DELIVERED. THE PT CLAIMED HE DISCONNECTED FROM THE PUMP AND WHEN HE LOOKED AT THE CARTRIDGE, THE CARTRIDGE WAS EMPTY. THE PT THEN CHANGED CARTRIDGE AND CONFIRMED THAT INSULIN CAME OUT IN A STREAM WITH CARTRIDGE CHANGE ON LOAD CARTRIDGE STEP. THE PT REPORTED FEELING "LOW" AND OBTAINED BLOOD GLUCOSE READINGS THAT RANGED FROM 18 MG/DL TO 37 MG/DL. THE PT STATED THE MD ON THE CRUISE SHIP TREATED HIM WITH GLUCOSE GEL AND MONITORED BOTH HIS BLOOD PRESSURE AND BLOOD GLUCOSE. THE PT CONFIRMED HIS BLOOD GLUCOSE LEVEL'S INCREASED (READINGS NOT PROVIDED). THE PT STATED HAS BEEN OFF THE PUMP AND ON BACKUP PLAN SINCE THE INJURY OCCURRED. AT THE TIME OF TROUBLESHOOTING, THEY CONFIRMED HE DID NOT PRIME THE PUMP WHILE ATTACHED. THE PT INSERTED A BATTERY INTO THE PUMP AND CLAIMED THAT THE DATE AND TIME WERE INCORRECT. THE PT REPORTED HE HAD REPLACED THE PUMP'S BATTERY ON (B)(6) 2011, AND AT THAT TIME, THE PUMP'S DATE/TIME REVERTED TO DEFAULT SETTINGS. THE PT CLAIMED HE BECAME AWARE OF PUMP'S INCORRECT DATE/TIME ON (B)(6) 2011. THE PUMP'S ALARM HISTORY INDICATED AN EMPTY CARTRIDGE ALARM WITH A DATE OF (B)(6) 2007. PRIME HISTORY REVEALED SMALL PRIME 0.6 ON (B)(6) 2011, DUE TO PUMP NOT STOPPING ON LOAD STEP. PRIOR TO THE INJURY, THE BOLUS HISTORY REVEALED A BOLUS DOSE OF 0 UNITS WAS PROGRAMMED AT 10:53AM AND 10:52AM ON (B)(6) 2011. THE PT FELT THE TIME ON THOSE BOLUS RECORDS WERE INCORRECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| R