BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3011444 · Received March 19, 2013

    Report

    Report Number
    2531779-2013-02833
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP HISTORY SHOWED THE PUMP HAD REBOOTED. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. A TEST CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP AND THE PUMP POWERED ON WITH A BLANK DISPLAY. A TEST DISPLAY WAS INSERTED FOR TESTING AND THE DISPLAY REMAINED BLANK. EVALUATION REVEALED THAT THE BOLUS BUTTON WAS MISALIGNED. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND IN THE BOLUS BUTTON. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE PRINTED CIRCUIT BOARD.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 250MG/DL AFTER THE PUMP LOST POWER AFTER THE PATIENT WAS SWIMMING. THE PATIENT WAS REPORTEDLY SWIMMING AND WATER GOT INTO THE PUMP. THE PATIENT WAS GOING TO DO A MEAL BOLUS AND NOTICED THAT THE PUMP WAS POWERED OFF. THE PATIENT WAS ABLE TO TREAT THEIR BLOOD GLUCOSE WITH ANOTHER INSULIN DELIVERY METHOD. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PUMP POWERED OFF WITHOUT USER INTERVENTION. THE BLOOD GLUCOSE EXCURSION DOES NOT CONSTITUTE AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114259 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR