BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1113319 · Received August 12, 2008

    Report

    Report Number
    3004464228-2008-00171
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED, SO NO EVALUATION IS POSSIBLE. THE CUSTOMER NOTICED A "CRUNCHING" SOUND 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 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 CRACKING 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

    CALLER STATES THIS POD MADE A LOUD CRUNCHING/CRINKLING SOUND WHEN SHE FILLED WITH INSULIN. CALLER STATES HER BLOOD GLUCOSE (BG) READINGS WENT FROM 115MG/DL TO 220MG/DL IN A FEW HOURS. SHE DID SEVERAL CORRECTION BOLUSES AND BG WENT TO 250MG/DL. SHE HAS KEPT THIS POD ON BUT HAS BEEN DOING CORRECTION BOLUSES BY INJECTION EVERY 2-3 HOURS. CALLER STATES THIS HAS HAPPENED WITH HER LAST THREE PODS AND SHE JUST KEEPS BOLUSING BY INJECTION. PODS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11708

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR