BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2933461 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01305
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    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 (PATIENT'S MOTHER) CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THE PUMP HAD A CRACK AROUND THE DISPLAY SCREEN, THE CONTRAST BUTTON WAS NOT FUNCTIONING AND THE TIME ON THE PUMP IS NOT BEING KEPT CORRECTLY SO THAT THE PATIENT HAS TO KEEP RESETTING THE TIME CORRECTLY. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. ANIMAS CUSTOMER TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, BUT WAS UNSUCCESSFUL IN THE ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER ALLEGED A PUMP MALFUNCTION WITH PUMP DAMAGE THAT REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39254 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR