BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2671242 · Received July 26, 2012

    Report

    Report Number
    2531779-2012-07153
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Report Date
    June 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PUMP WAS RETURNED WITH THE AUDIO BOLUS BUTTON DETACHED AND VISIBLE MOISTURE IN DISPLAY LENS. THE PUMP WOULD NOT POWER ON: UNABLE TO DOWNLOAD PUMP AND COMPLETE REQUIRED INVESTIGATION STEPS DUE INABILITY TO POWER ON PUMP. AN AUDIO BOLUS BUTTON LEAK FOUND DURING IN HOUSE LEAK TEST. THE PUMP COVER WAS REMOVED AND MOISTURE WAS SEEN TO BE PRESENT IN PUMP. USER ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING ACTOR , AS THE ABSENCE OF THE AUDIO BOLUS BUTTON AFFECTS THE WATERPROOF FEATURE OF THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. ANIMAS HAS 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THAT THE PUMP HAD NO POWER AT THE TIME OF THE CALL. THE REPORTER STATED THAT MANY DIFFERENT BATTERIES HAD BEEN TRIED IN THE PUMP AND THERE WAS STILL NO POWER TO THE PUMP. THE REPORTED CONFIRMED THAT THE BATTERY CAP IS LESS THAN ONE MONTH OLD THE BATTERY CAP WAS SECURED TIGHTLY TO THE PUMP AND THERE WERE NO VISIBLE CRACKS IN THE BATTERY COMPARTMENT. THE REPORTER STATED THAT THERE IS MOISTURE VISIBLE BEHIND THE DISPLAY SCREEN. THE REPORTER CONFIRMED THERE IS NO MOISTURE OBSERVED IN THE BATTERY OR CARTRIDGE COMPARTMENT. THE REPORTER STATED THAT THE AUDIO BOLUS BUTTON WAS MISSING FROM THE PUMP AND THE PATIENT KNOWINGLY WORE THE PUMP TO THE BEACH THAT DAY, WHERE IT WAS EXPOSED TO MOISTURE. THIS COMPLAINT IS BEING REPORTED ON THE BASIS OF THE ALLEGED POWER LOSS.

    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 12 YR