BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2982433 · Received November 22, 2006

    Report

    Report Number
    3004464228-2006-12218
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    October 26, 2006
    Report Date
    November 22, 2006
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DATA DOWNLOAD REVEALED NO ALARMS HAD OCCURRED AND THE POD RAN FOR 1890 PULSES (APPROXIMATELY 24 HOURS) BEFORE IT WAS REMOVED AND DEACTIVATED. EVALUATION OF THE CANNULA TIP DETERMINED THAT THE TIP WAS SLIGHTLY DAMAGED BUT NOT SUFFICIENTLY TO STOP INSULIN DELIVERY. THE DAMAGED CANNULA TIP MAY HAVE REDUCED THE LEVEL OF INSULIN DELIVERY, BUT THE POD DATA DID NOT INDICATE THAT IT HAD OCCLUDED. EVALUATION OF THE DRIVE AND MECHANICAL ASSEMBLY DID NOT REVEAL ANY FUNCTIONAL ISSUES.

    Description of Event or Problem · 1

    CUSTOMER SAID THAT THEY HAD TWO PODS WHICH THEY DID NOT THINK WERE DELIVERING INSULIN CORRECTLY. THE FIRST WAS DISCARDED AND THERE IS NO FURTHER INFORMATION AVAILABLE. THE SECOND POD (LOT AND SEQUENCE NUMBERS NOTED) WAS RETURNED TO MFR FOR EVALUATION. THEY CHECKED THE PATIENTS BLOOD GLUCOSE AND IT REGISTERED "HI", AND THEY REMOVED THE POD. AT THIS TIME (TIME OF CALL), SHE SAID THEY HAD CALLED THE USER'S DOCTOR, AND WERE WAITING FOR A RESPONSE TO SEE HOW MUCH INSULIN TO TAKE VIA INJECTION. IT WAS REPORTED THAT THE PATIENT'S INFUSION SITE LOOKED "NORMAL", AND WAS NOT BUMPY, RED, OR WET. SHE SAID THERE WAS NO BLOOD IN THE CANNULA, AND THE CANNULA WAS NOT BENT OR KINKED. SHE SAID THE INSULIN HAD BEEN KEPT REFRIGERATED BEFORE THEY PUT IT IN THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L10755

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other| R