BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2180579 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05345
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 PATIENT REPORTED THAT ON (B)(6) 2011 HE NOTICED THAT THE TIME AND DATE WERE INCORRECT ON THE PUMP. HE STATED THAT HE DOES NOT RECALL IF THE PUMP WAS ON THE VERIFY SCREEN OR NOT. THE PATIENT STATED THAT ON THE EVENING OF (B)(6) 2011, HE RECEIVED A "NO PRIME" MESSAGE AND HAD TO COMPLETE A FULL REWIND. CUSTOMER SUPPORT CONCLUDED THAT THE PUMP MAY HAVE REBOOTED WITHOUT USER INTERVENTION. THE PATIENT CONFIRMED THAT THERE IS NO DAMAGE TO THE BATTERY COMPARTMENT AND THE BATTERY CAP TIGHTENS SECURELY TO THE PUMP. THE PATIENT NOTED THAT THE BATTERY CAP IS ORIGINAL TO THE PUMP FROM 2006. THE USER GUIDE RECOMMENDS THAT THE BATTERY CAP BE CHANGED EVERY SIX MONTHS. THIS COMPLAINT IS BEING REPORTED DUE TO THE POSSIBILITY THAT THE PUMP WAS REBOOTING WITHOUT USER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR