BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2071745 · Received April 19, 2011

    Report

    Report Number
    2531779-2011-02705
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S MOTHER, REPORTED THAT ON (B)(6) 2011, THE PATIENT OBTAINED BLOOD GLUCOSE READINGS 'GREATER THAN 600 MG/DL'. DURING THAT TIME PERIOD, THE PATIENT EXPERIENCED THE SYMPTOMS OF EXCESSIVE THIRST AND FREQUENT URINATION. THE PATIENT CONTACTED THE PHYSICIAN, WHO ADVISED THE PATIENT TO TAKE INJECTIONS OF INSULIN VIA A SYRINGE AND DISCONNECT FROM THE PUMP. THE PATIENT HAD NOT BEEN SICK AND HAD NOT BEEN ON ANY NEW MEDICATIONS. TROUBLESHOOTING REVEALED NO ISSUES WITH THE INFUSION SITE, NO LEAKS IN THE CANNULA OR CARTRIDGE, THE PUMP'S DATE/TIME WERE CORRECT AND THE PUMP HISTORY OF BOLUS DOSES MATCHED THOSE PROGRAMMED. THE TECHNICAL SERVICE REPRESENTATIVE ALSO DETERMINED THAT ON (B)(6) 2011, THE INSULIN PUMP DELIVERED A TOTAL OF 14.85 UNITS BASAL INSULIN, AND THE PUMP HAD BEEN PROGRAMMED TO DELIVER 15.60 UNITS DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R