BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3070583 · Received April 12, 2013

    Report

    Report Number
    3004464228-2013-00343
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 17, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. THE CUSTOMER REPORTED KNOCKING THE POD AND LATER FEELING INSULIN DELIVERY OUTSIDE THE BODY. A LOOSE OR DISLODGED POD OR CANNULA COULD CONTRIBUTE TO HYPERGLYCEMIA. THE OMNIPOD USER GUIDE WARNS "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY," "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN - USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY," "IF YOUR READING IS ABOVE 50 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA," AND "'LOW' OR 'HIGH' BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH. "NO QUALIFICATION RECORDS COULD BE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HER BLOOD GLUCOSE WAS IN NORMAL RANGE FOR THE FIRST DAY SHE WORE THE DEVICE AND PART OF THE SECOND DAY. DURING THE SECOND DAY, SHE STATED THAT SHE KNOCKED THE POD AND COULDN'T TELL IF THE POD OR CANNULA WAS LOOSE BECAUSE IT WAS ON HER BACK. SHE WENT TO GIVE HERSELF A BOLUS AND FELT THE INSULIN DRIP DOWN HER BACK. HER BLOOD GLUCOSE READ "HIGH" (>500 MG/DL) AT THAT POINT. SHE WENT TO THE HOSPITAL WHERE SHE WAS ADMITTED FOR HER BG AND TREATED WITH IV FLUIDS AND MANUAL INJECTIONS OF LONG AND FAST-ACTING INSULINS. SHE WAS RELEASED THE FOLLOWING DAY. THE POD WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158297 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization