BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1920954 · Received December 7, 2010

    Report

    Report Number
    3004464228-2010-01415
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    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 RETURNED FOR EVAL WITH THE NEEDLE UNDEPLOYED. THE INVESTIGATION CONFIRMED THAT DAMAGE TO THE CHASSIS CAM FINGER PREVENTED THE NEEDLE MECHANISM FROM DEPLOYING. THE DEVICE TERMINATED WITH HAZARD ALARM CODE 0X1C PUMP IN PRIMARY POSITION. THE PIEZO WAS TESTED AND PERFORMED AS EXPECTED, INDICATING THAT THE ALARM WOULD HAVE BEEN AUDIBLE TO THE USER. THE USER FAILED TO NOTE THAT THE CANNULA HAD NOT DEPLOYED UPON PLACING THE POD, WHICH WOULD HAVE BEEN VISIBLE THROUGH THE VIEWING PORT. THE OMNIPOD USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED". HAD USER GUIDE INSTRUCTIONS BEEN PROPERLY FOLLOWED, THE POD WOULD HAVE IMMEDIATELY BEEN REMOVED AND REPLACED UPON NOTICING THAT THE CANNULA HAD NOT DEPLOYED. THE CUSTOMER PROCEEDED TO WEAR THE POD DESPITE THE MALFUNCTION, WHICH RESULTED IN HIGH BG LEVELS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE "NEEDLE DEPLOYED, BUT THE CANNULA NEVER CAME OUT." HER BG LEVELS WERE "RUNNING HIGH ALL DAY" (NO SPECIFIC BG'S WERE PROVIDED, BUT LEVELS ARE ASSUMED TO BE GREATER THAN 250MG/DL). THE POD WAS WORN ON THE CUSTOMER'S LEG; SHE WAS, THEREFORE, "NOT ABLE TO SEE IF IT (THE CANNULA) WAS INSERTED CORRECTLY." IT IS UNK HOW LONG THE POD WAS WORN FOR. THE DEVICE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUNSION, INSULIN LZG INSULET CORPORATION 11200 L30407

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other