BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1132136 · Received August 22, 2008

    Report

    Report Number
    3004464228-2008-00187
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED SO NO EVALUATION IS POSSIBLE. THE CUSTOMER NOTICED A LOT OR RESISTANCE DURING THE FILL PROCESS WHICH INDICATES A PROBABLE PROBLEM WITH THE RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE. THIS DAMAGE PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD NAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT IN FILLING THE POD WITH INSULIN AND A DISTINCT "CRACKING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURIZED. 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 RESULT IN UNDER-DELIVERY OF INSULIN." THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO MONITOR BLOOD GLUCOSE LEVELS FREQUENTLY. BY FOLLOWING THESE RECOMMENDATIONS, THE USER BECAME AWARE OF THEIR HIGH BLOOD GLUCOSE AND STARTED A NEW POD OR BACKUP THERAPY IF NEEDED.

    Description of Event or Problem · 1

    CUSTOMER'S DOCTOR RELAYED THIS INFORMATION TO INSULET REPRESENTATIVE. THE PATIENT WAS TRAVELING AND HAD 2 PODS HE DID NOT THINK WORKED CORRECTLY. CUSTOMER DESCRIBED NOT BEING ABLE TO EASILY INJECT INSULIN INTO 2 PODS, SO HE "FORCED" HE INSULIN IN. HE WORE ONE OF THE PODS FOR SEVERAL HOURS AND HIS BLOOD GLUCOSE (BG) LEVELS ROSE ABOVE 330MG/DL. AS INSTRUCTED BY HIS PHYSICIAN, IF BG IS ABOVE 300MG/DL, HE SHOULD SEEK ASSISTANCE. CUSTOMER WENT TO A LOCAL HOSPITAL TO GET HIS BG LEVELS UNDER CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention