BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2070963 · Received April 20, 2011

    Report

    Report Number
    3004464228-2011-00163
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS THOROUGHLY EVALUATED. A REVIEW OF THE DOWNLOAD DATA SHOWS THAT ON (B)(6) 2011 AT 1:49 PM THE USER ACTIVATED A POD AND A BLOOD GLUCOSE READING OF 243 MG/DL WAS RECORDED. THE USER BOLUSED 2.85 IU OF INSULIN, THEN AT 9:05 AM ON (B)(6) 2011 THE CUSTOMER RECEIVED A BG READING OF 128 MG/DL. THE CUSTOMER THEN ENTERED 26G OF CARBOHYDRATES AND EXECUTED A CALCULATED BOLUS OF 2.10 IU OF INSULIN. THEN AT 11:49 AM A BG READINGS WAS ATTEMPTED AND THE USER RECEIVED A METER ERROR 4. THIS WAS FOLLOWED SIXTY ONE SECONDS LATER BY A CLOCK RESET; THE DATE WAS REENTERED AS (B)(6) 2011. THE PDM WAS NOT USED AGAIN UNTIL (B)(6) 2011. FUNCTIONAL TESTING OF THE BLOOD GLUCOSE MONITORING FUNCTIONS OF THE DEVICE COULD NOT BE COMPLETED IN AS-RETURNED CONDITION, DUE TO A PCB FIRMWARE CORRUPTION, THE ROOT CAUSE OF WHICH COULD NOT BE DETERMINED. THE NONFUNCTIONAL STATE OF THE BLOOD GLUCOSE METER AS REPORTED BY THE CUSTOMER WAS THEREFORE CONFIRMED. THE TIME LINE RECOVERED FROM THE DEVICE'S MEMORY, HOWEVER, INDICATES THAT THE DEVICE WAS FUNCTIONING PRIOR TO THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT HER BLOOD GLUCOSE LEVELS WERE LOW YESTERDAY WHILE SHE WAS DRIVING AND SHE CRASHED HER CAR. SHE FOUND OUT FROM THE EMT THAT HER BLOOD GLUCOSE LEVEL WAS 34 MG/DL. SHE EXPLAINED THAT THE EMTS TRIED TO USE HER OMNIPOD PDM TO CHECK HER BG LEVEL AND WHEN THEY PUT IN THE TEST STRIP THE PDM SHUT OFF. NO SPECIFICS OF ANY MEDICAL INTERVENTION BY THE EMTS WERE REPORTED. THE PDM WAS THEN LEFT IN THE CAR FOR A COUPLE OF DAYS AND WHEN SHE WAS FINALLY ABLE TO GET TO IT, IT WOULD NOT WORK AND TEST HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L12043

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other