BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2082176 · Received April 29, 2011

    Report

    Report Number
    3004464228-2011-00183
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 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 EVAL OF THE RETURNED PRODUCT FOUND EVIDENCE OF AN INTERNAL FLUID LEAK, INCLUDING DISCOLORATION AND BLOOD INSIDE THE DEVICE. A LEAK TEST WAS PERFORMED WHICH CONFIRMED A LEAK IN THE FLUID PATH. A TEAR WAS FOUND IN THE CANNULA TUBING. THIS WOULD RESULT IN INSULIN COMING INTO CONTACT WITH INTERNAL COMPONENTS AND ASSEMBLIES, ULTIMATELY CAUSING THE DEVICE TO FAIL. A DEVICE MALFUNCTION IS THEREFORE CONFIRMED AS A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BLOOD GLUCOSE. THERE WAS EVIDENCE OF THIS DEFECT MODE IN LOT ACCEPTANCE TESTING FOR THIS POD LOT (L30450); RESULTS WERE DEEMED ACCEPTABLE. RISK LEVEL TO THE PT WAS DETERMINED TO BE EXTREMELY LOW (3.4 IN 10,000). DIABETICS ARE TRAINED TO MONITOR THEIR BGS ON A REGULAR BASIS. INSULET PROVIDES LABELING REFERENCING THIS MONITORING. ADDITIONALLY, THE PRODUCT LABELING INSTRUCTS THE CUSTOMER TO "TAKE A SECOND BOLUS BY INJECTION USING A STERILE SYRINGE" IF A DEVICE-ADMINISTERED BOLUS HAS NOT CORRECTED A HIGH BG CONDITION AFTER TWO HRS. 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 BLOOD GLUCOSE LEVEL MEASURED 370 MG/DL AT 1:00 A.M. AT WHICH TIME A 10 UNIT INSULIN BOLUS WAS ADMINISTERED. BLOOD GLUCOSE REMAINED HIGH, REACHING 450 MG/DL AT 5:30. THE CUSTOMER ALSO NOTICED A BRUISE AROUND WHERE THE EDGES OF THE POD WAS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30450

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other