BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1250542 · Received November 14, 2008

    Report

    Report Number
    3004464228-2008-00304
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 19, 2008
    Report Date
    October 19, 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 EVAL IS POSSIBLE. THE CUSTOMER NOTICED A "CRACKLING' NOISE DURING THE FILL PROCESS WHICH INDICATES A PROBABLE PROBLEM WITH THE RETAINER THAT ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE. THIS DAMGE 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 BACKUP THERAPY IF NEEDED.

    Description of Event or Problem · 1

    CUSTOMER STATED SHE HAD A POD THAT WAS HARD TO FILL AND MADE A CRACKLING SOUND, BUT ACTIVATED THE POD ANYWAY. SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (BG'S) THAT RANGED BETWEEN 187-445 MG/DL OVER THE 7 HOURS SHE WORE THE POD BEFORE TAKING IT OFF. SHE WAS ABLE TO ACTIVATE A NEW POD. REVIEWED LABELING INSTRUCTIONS WITH THE CUSTOMER. 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 L30024

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other