BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3211514 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09740
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2013 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES . THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PUMP WAS PRIMED AND EXERCISED FOR 24 HOURS, NO DELIVERY INTERRUPTION OCCURRED DURING THE COURSE OF TESTING. THE PUMP PASSED 29 HOUR FLOW ACCURACY TEST. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING BLOOD GLUCOSE LEVELS IN THE 500+ MG/DL RANGE WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT REPORTED HAVING BLOOD GLUCOSE LEVELS RESPOND NORMALLY WITH INJECTIONS BUT BLOOD GLUCOSE LEVELS INCREASED WHEN USING THE PUMP. DURING A REVIEW OF THE PUMP, THE PATIENT INDICATED THAT THE BOLUS HISTORY ON THE PUMP WAS INCORRECT; THE REPORTER INDICATED THAT THE BOLUS HISTORY INDICATED 96.7 UNITS BUT IT SHOULD ONLY HAVE SHOWN 52 UNITS. THE PATIENT ALSO INDICATED THAT THE PUMP SHOWED A TEMPORARY BASAL THE PREVIOUS DAY ONLY GIVING 9.9 UNITS OF BASAL INSULIN BUT THE PATIENT DENIED USING THE TEMPORARY BASAL RATE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION OF A DISCREPANCY IN THE PUMP DELIVERY HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308793 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening