BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1220816 · Received October 30, 2008

    Report

    Report Number
    3004464228-2008-00282
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 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 WAS RETURNED AND EVALUATED. THE EVALUATION 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 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 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 BACK UP THERAPY IF NEEDED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO SAY THAT HE PLACED A NEW POD ON LAST NIGHT AROUND 8:00PM AND WORK UP IN THE MIDDLE OF NIGHT WITH VERY HIGH BLOOD GLUCOSE (BG). BETWEEN 8:00PM AND 12:30AM HIS BG RANGED 145-400 MG/DL. HE GAVE HIMSELF A MANUAL INSULIN INJECTION AND IT BROUGHT HIS BG DOWN TO 101 MG/DL BEFORE CHANGED THIS POD. NO FURTHER ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11832

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other