BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251650 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00498
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 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 POD WAS RECEIVED DISASSEMBLED AND DISCOLORATION WAS SEEN INSIDE THE DEVICE. 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 CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BLOOD GLUCOSE. A REVIEW OF LOT QUALIFICATION RECORDS REVEALED NO EVIDENCE OF THIS FAILURE MODE. LOT QUALIFICATION RESULTS WERE DEEMED ACCEPTABLE AND THE LOT PASSED THE ACCEPTANCE CRITERIA. INSULET HAS INITIATED AN INTERNAL INVESTIGATION INTO THIS PARTICULAR FAILURE MODE AND HAS TAKEN MULTIPLE ACTIONS TO MINIMIZE AND PREVENT ITS RECURRENCE. A RISK ASSESSMENT HAS ALSO BEEN CONDUCTED AS WELL AS ONGOING MONITORING TO ENSURE THAT THIS LEVEL OF FAILURE DOES NOT EXCEED ACTION LIMITS (AS DIRECTED BY INSULET'S INTERNAL PROCEDURES).

    Description of Event or Problem · 1

    A CUSTOMER ACTIVATED A POD ON (B)(6) 2011 AT 10:55 PM AND SHORTLY AFTER (WITHIN THE HOUR) SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS (<70MG/DL). THEN, AT 3:01 AM, SHE HAD A BG OF 261 MG/DL AND ADMINISTERED 0.3 UNITS OF INSULIN. HER BG CONTINUED TO RISE, AT 4:51 AM, IT READ 333 MG/DL SO SHE ADMINISTERED 1 UNIT OF INSULIN. AT 4:55 AM, SHE CHANGED PODS. THE CUSTOMER REPORTED "THE POD HAS A CONTINUOUS TICK TO IS" AND NOTICED RUST ON TOP OF THE POD. THE DEVICE 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 L30597

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR