BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2003093 · Received February 8, 2011

    Report

    Report Number
    2531779-2011-00693
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. ANIMAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD CARTRIDGE PHASE. THE PATIENT STATED THAT HE HAD RECEIVED RANDOM LOSS OF PRIME WARNINGS FOR ABOUT THREE MONTHS. FOR THE LAST TWO WEEKS, HE RECEIVED TWO OR THREE LOSS OF PRIME WARNINGS EACH DAY. THE PATIENT SAID THAT HE DISCONNECTED FROM THE INFUSION SITE AND RE-PRIMED THE PUMP SUCCESSFULLY EACH TIME. HE REPORTED THAT HE CHANGED THE CARTRIDGE RECENTLY AND THE PUMP PUSHED ALL OF THE INSULIN OUT OF THE CARTRIDGE DURING THE LOAD CARTRIDGE STEP. THE PATIENT SAID THAT HE REFILLED THE CARTRIDGE AND THE PUMP LOADED CORRECTLY THE SECOND TIME. HE CONFIRMED THAT HE WAS ABLE TO COMPLETE THE EZPRIME STEPS AND SAW DROPS OF INSULIN AT THE END OF TUBING. SINCE THAT TIME, HE REPLACED THE CARTRIDGE FROM DIFFERENT BOXES THREE TIMES AND MULTIPLE LOSS OF PRIME WARNINGS CONTINUE. THE PATIENT DENIED ANY FURTHER INSTANCES OF INSULIN DISPENSING DURING THE LOAD CARTRIDGE STEP.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR