BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1082847 · Received July 25, 2008

    Report

    Report Number
    3004464228-2008-00149
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 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 EVALUATION INDICATES THAT A RETAINER ALLOWED 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 THE 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 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

    A CUSTOMER'S MOTHER CALLED IN TO REPORT THAT HER SON HAD HIGH READINGS. SHE STATED THAT A COUPLE OF CORRECTION BOLUS WERE INITIATED, BUT IT DID NOT COME DOWN. SHE STATED THAT SHE CHANGED THE POD, BUT THEY STILL HAD A HIGH READING. WHILE SPEAKING WITH MOTHER, IT WAS DETERMINED THAT THE POD HAD CRACKLING NOISES AND WAS HARD TO FILL. SHE WAS ABLE TO ACTIVATE A NEW POD. NO FURTHER PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11683

    Patients

    Seq Age Sex Outcome Treatment
    1 Other