BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3220794 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10306
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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: DATE OF SUBMISSION 10/29/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2013 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. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING ELEVATED BLOOD GLUCOSE LEVELS OVER THE LAST COUPLE OF DAYS TO 15MMOL/L WITH NO KETONES OR SYMPTOMS PRESENT. THE REPORTER STATED THAT THE BLOOD GLUCOSE LEVELS WERE NOT COMING DOWN WITH EXTRA BOLUSES AND INCREASED BASAL RATES. THE PATIENT REPORTED HAVING AN AIR BUBBLE IN THE CARTRIDGE AND REPORTED HAVING A BENT CANNULA IN THE INFUSION SET HOWEVER THE PATIENT WAS INSISTENT THAT THERE WAS A PUMP ISSUE CAUSING THE ELEVATIONS. THE PUMP WAS REVIEWED WITH THE PATIENT AND FOUND NO INDICATIONS OF MECHANICAL ISSUES WITH THE PUMP. THE REPORTED BLOOD GLUCOSE DOES NOT MEET ANIMAS CRITERIA FOR AN ADVERSE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF A PUMP DELIVERY MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320889 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR