BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2072614 · Received April 22, 2011

    Report

    Report Number
    3004464228-2011-00171
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 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 INSIDE THE DEVICE AND CORROSION AND RESIDUAL FLUID ON THE SURFACES OF INTERNAL ASSEMBLIES. 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 THE POD LOT (L30453); RESULTS WERE DEEMED ACCEPTABLE. RISK LEVEL TO THE PT WAS DETERMINED TO BE EXTREMELY LOW (1.35 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 AND, "IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HRS (A TOTAL OF 4 HRS), REPLACE THE POD." 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 CALLED IN TO ASK WHETHER TO REPLACE THE DEVICE. SHE HAD BEEN BOLUSING (EXACT TIMES AND DOSAGES UNK) AND HER BLOOD GLUCOSE WAS MEASURING "HIGH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30453

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other