BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1080117 · Received July 17, 2008

    Report

    Report Number
    3004464228-2008-00139
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    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 PRODUCT WILL NOT BE RETURNED SO NO EVALUATION WAS POSSIBLE. THE CUSTOMER FELT RESISTANCE DURING THE FILL PROCESS, WHICH INDICATES A PROBABLE PROBLEM WITH A RETAINER THAT ALLOW A COMPONENT TO MOVE RESULTING IN DAMAGE WHICH PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD HAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT IN FILLING THE POD WITH INSULIN AND A DISTINCT "CRACKLING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURISED. THE OMNIPOD USER GUIDE STATES: "WARNING:NEVER USE A POD IF, DURING FILL, YOU DETECT ANY CRACKLING NOISE OR RESISTANCE WHILE DEPRESSING THE PLUNGER OF THE FILL SYRINGE. USING A POD WITH THESE CONDITIONS COULD RESULTS IN UNDER-DELIVERY OF INSULIN." THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER'S COMPLAINT AGAINST THIS POD WAS THAT ALTHOUGH IT WAS DIFFICULT TO PUT THE INSULIN IN THE POD, SHE WAS ABLE TO DO SO. SHE STATED THAT AT THAT TIME HER BG WAS 168 BUT AS SHE CONTINUED TO WEAR THE POD HER BG LEVEL BEGAN TO RISE - 2:25AM 346 AND 2:49AM 365. SHE THEN CALLED PRODUCT SUPPORT AND WAS ASSISTED IN ACTIVATING A NEW POD. REVIEWED PRODUCT IFU WITH CUSTOMER REGARDING PODS THAT ARE HARD TO FILL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other