BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2323285 · Received November 2, 2011

    Report

    Report Number
    3004464228-2011-00544
    Event Type
    Injury
    Date Received
    November 2, 2011
    Date of Event
    October 30, 2009
    Report Date
    October 31, 2009
    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 DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE PRODUCT CONDITION OR DETERMINE WHETHER THE MALFUNCTION CONTRIBUTED TO THE PT'S HOSPITALIZATION. QUALIFICATION RECORDS FOR THE PRODUCT LOT WERE REVIEWED AND ALL ACCEPTANCE CRITERIA WERE MET. THE OMNIPOD USER'S GUIDE ADVISES THAT "THE PDM IS BUILT TO WITHSTAND REASONABLE AMOUNTS OF ABUSE, BUT SHOCK OR A SEVERE IMPACT CAN DAMAGE IT. IF YOU DROP THE PDM OR IF IT IS OTHERWISE SUBJECTED TO SEVERE IMPACT: INSPECT THE OUTSIDE OF THE PDM FOR VISIBLE SIGNS OF DAMAGE. PRESS AND HOLD THE POWER BUTTON TO SEE WHETHER THE PDM TURNS ON AND WHETHER THE LCD SCREEN IS DAMAGED. INSPECT THE INSIDE OF THE BATTERY COMPARTMENT FOR VISIBLE SIGNS OF DAMAGE. DO NOT USE THE PDM IF IT APPEARS DAMAGED OR IS NOT WORKING AS IT SHOULD. FOR 24-HOUR CUSTOMER CARE, CALL 800-591-3455." IT ALSO CAUTIONS THAT, "IF YOU EVER NEED TO RETURN THE PDM FOR REPAIR OR REPLACEMENT, CONTACT YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON GOING BACK TO TREATMENT BY INJECTIONS." THE USER'S GUIDE WARNS THAT "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND ADVISES THAT "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    PT REPORTED THAT HIS BLOOD GLUCOSE AT 8:00 AM ON (B)(6) 2009 WAS 318 MG/DL, SO HE TOOK A 6 UNIT INSULIN BOLUS. BY 11:30 HE WAS EXPERIENCING CHEST PAIN AND DIFFICULTY BREATHING, AND HIS BLOOD GLUCOSE MEASURED 465 MG/DL. AT "E:00 PM" HE WENT TO THE EMERGENCY ROOM WHERE THEY TESTED HIS BG AT GREATER THAN 600 MG/DL. THEY REMOVED HIS POD, WHICH WAS ALARMING AT THE TIME, AND PLACED HIM ON AN INSULIN DRIP. ON (B)(6) TREATMENT WAS CHANGED TO 6 UNITS/HOUR BY INJECTION. HE WON'T BE DISCHARGED UNTIL TESTS RELATING TO CARDIAC ISSUES ARE COMPLETED. THE PT'S PDM, WHICH HE REPORTED DROPPING THE DAY PRIOR TO THE EVENT, WOULD NOT EVEN TURN ON DURING THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11360 L12005

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization