BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2051507 · Received April 4, 2011

    Report

    Report Number
    3004464228-2011-00132
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 3, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED POD FOUND EVIDENCE OF AN INTERNAL FLUID LEAK. DISCOLORATION WAS SEEN INSIDE THE DEVICE AND RESIDUAL FLUID WAS FOUND ON THE SURFACES OF INTERNAL ASSEMBLIES. A LEAK TEST WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF A LEAK IN THE FLUID PATH CAUSED BY A TEAR IN THE CANNULA TUBING. THE LEAK WOULD HAVE RESULTED IN INSULIN COMING INTO CONTACT WITH INTERNAL COMPONENTS AND ASSEMBLIES, ULTIMATELY CAUSING THE DEVICE TO FAIL. A POD MALFUNCTION, THEREFORE, IS CONFIRMED TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS. THERE WAS EVIDENCE OF THIS DEFECT MODE DURING LOT TESTING FOR THIS POD LOT (L30451), ULTIMATE RESULTS WERE DEEMED ACCEPTABLE AND WE EVALUATED AND DETERMINED THE LEVEL OF RISK TO THE PT WAS EXTREMELY LOW (1 IN 10,000). DIABETICS ARE TRAINED TO MONITOR THEIR BG'S ON A REGULAR BASIS AND INSULET TRAINS AND PROVIDES LABELING REFERENCING THE SAME. DUE TO THE MONITORING THE PT DID REALIZE THAT THERE WAS AN ISSUE, AND TOOK APPROPRIATE ACTION. THEIR WAS NO ADVERSE EVENT. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO IDENTIFY THE ROOT CAUSE OF THIS FAILURE MODE. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER HAS EXPERIENCED HIGH BGS (449MG/DL UP TO A 'HIGH' READING) AFTER WEARING THE POD FOR 2 HRS. AFTER THE FIRST HIGH BG READING, SHE ADMINISTERED A CORRECTION BOLUS. CUSTOMER'S MOTHER REPORTED THAT AFTER CHECKING HER BG AN HR LATER, THE PDM READ HIGH. SHE TREATED THE HIGH BG WITH MANUAL INJECTIONS THROUGHOUT THE NIGHT AND DID NOT REMOVE THE POD UNTIL THE NEXT MORNING. UPON REMOVAL OF THE POD, THE CUSTOMER'S MOTHER NOTICED SOME DISCOLORATION INSIDE THE POD. THE POD WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30451

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other