BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2906895 · Received January 10, 2013

    Report

    Report Number
    2531779-2013-00467
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 13, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 04/04/2013-46) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE PUMP BLACK BOX OR DOWNLOAD HISTORY. NO PERFORMANCE TESTING WAS ABLE TO COMPLETED DUE TO AN UNRELATED KEYPAD UNRESPONSIVE ISSUE.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THERE WERE BUTTON ISSUES WITH THE PUMP AND THE PATIENT'S ENDOCRINOLOGIST STATED THAT IT IS TIME FOR A NEW PUMP . THE REPORTER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 300 MG/DL AND UP TO JUST BELOW 500MG/DL WITH MODERATE KETONES AND CRANKINESS. THE PATIENT WAS TREATED WITH FLUIDS AND A BOLUS VIA THE PUMP. THE REPORTER ALSO REPORTED THAT THERE WERE BUTTONS ISSUES WITH THE PUMP. CUSTOMER SUPPORT (CS) ADVISED REPORTER TO MONITOR THE BUTTONS CLOSELY AND IF CANNOT PROGRAM PUMP SAFELY TO GO ON A BACK UP PLAN. CS ALSO ADVISED REPORTER TO CHECK PUMP HISTORY THOROUGHLY. THE REPORTER ALSO THAT THERE WAS A CHANGE IN PHYSICAL ACTIVITY OF THE PATIENT. THIS REPORT IS BEING MADE BECAUSE THE USE OF AN INSULIN PUMP AND CHANGE IN PHYSICAL ACTIVITY CONTRIBUTED TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14832 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening