BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3111005 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06324
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. 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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED NO ACTIVITY RELATED TO THE COMPLAINT RECORDED IN THE PUMP HISTORIES. THREE DIFFERENT INSULIN-TO-CARBOHYDRATE (I:C) RATIO SETTINGS WERE PROGRAMMED IN THE PUMP (12AM-5:30AM I:C = 1U:27, 5:30AM-10AM I:C = 1U:8, 10AM-12AM I:C = 1U:10. 2). USING THE PATIENT¿S SETTINGS FOR INVESTIGATION, AN EZ-CARB BOLUS WAS PERFORMED FOR 95 CARBOHYDRATES AND THE PUMP CORRECTLY CALCULATED THE UNIT BOLUS. NONE OF THE I:C RATIO SETTINGS IN THE PUMP RESULTED IN A 8.12 UNIT BOLUS AT 95 CARBOHYDRATES. USING THE PATIENT¿S SETTINGS, AN EZ-CARB BOLUS WAS PERFORMED FOR 80 CARBOHYDRATES AT TARGET BLOOD GLUCOSE AND THE PUMP CORRECTLY CALCULATED A 10 UNIT BOLUS. INVESTIGATION WAS UNABLE TO VERIFY OR DUPLICATE THE COMPLAINT. THE PUMP WAS FOUND TO BE DELIVERING INSULIN AS INTENDED AND WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE; INCORRECT INSULIN-TO-CARBOHYDRATE CALCULATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212440 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR