BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2915799 · Received January 15, 2013

    Report

    Report Number
    2531779-2013-00662
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/06/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED USER¿S PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE NORMAL PATIENT USE OBSERVED IN PUMP HISTORIES. THERE WAS NO DATA IN PUMP HISTORIES FROM TIME OF REPORTED HIGH BG DUE TO CONTINUED USE. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED SUCCESSFULLY AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE HISTORY SETTINGS ISSUE WAS NOT DUPLICATED DURING TESTING. THERE WAS NO DEFECT FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING BLOOD GLUCOSE LEVELS UP TO HIGH ON THE METER (OVER 33 MMOL/L). THE PATIENT REPORTED DISCONNECTING FROM THE PUMP TO GO FOR A SWIM. THE PATIENT REPORTED A BLOOD GLUCOSE OF 28.6 MMOL/L AFTER SWIMMING. THE PATIENT REPORTEDLY CHANGED THE INFUSION SITE AND ADMINISTERED A CORRECTION BOLUS FOR THE BLOOD GLUCOSE AND FOR FOOD INTAKE. THE PATIENT INDICATED THAT 45 MINUTES LATER BLOOD GLUCOSE LEVELS HAD INCREASED TO HIGH. THE PATIENT INDICATED THAT OCCASIONALLY, BLOOD GLUCOSE LEVELS WOULD ELEVATE AFTER EXERCISE. THE PATIENT INDICATED THAT THE PUMP SETTINGS WERE CORRECT. CUSTOMER SUPPORT ADVISED THE PATIENT TO TRY CHANGING THE INFUSION SET AND MONITOR BLOOD GLUCOSE LEVELS AND CALL BACK TO ANIMAS WITH ANY FURTHER ISSUES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23100 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening