BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3001742 · Received March 7, 2013

    Report

    Report Number
    3004464228-2013-00196
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 6, 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

    NO PRODUCT WAS RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT ADVISES "ANY PHYSICAL STRESS CAN CAUSE YOUR BLOOD GLUCOSE TO RISE, AND ILLNESS IS A PHYSICAL STRESS. YOUR HEALTHCARE PROVIDER CAN HELP YOU MAKE A PLAN FOR SICK DAYS. THE FOLLOWING ARE ONLY GENERAL GUIDELINES. WHEN YOU ARE ILL, CHECK YOUR BLOOD GLUCOSE MORE OFTEN (AT LEAST ONCE EVERY 2 HOURS) TO AVOID DKA. THE SYMPTOMS OF DKA ARE MUCH LIKE THOSE OF THE FLU. BEFORE ASSUMING YOU HAVE THE FLU, CHECK YOUR BLOOD GLUCOSE TO RULE OUT DKA," AND "TO HANDLE SICK DAYS TREAT THE UNDERLYING ILLNESS TO PROMOTE FASTER RECOVERY, EAT AS NORMALLY AS YOU CAN AND ADJUST BOLUS DOSES, IF NECESSARY, TO MATCH CHANGES IN MEALS AND SNACKS. ALWAYS CONTINUE YOUR BASAL INSULIN, EVEN IF YOU ARE UNABLE TO EAT. CONTACT YOUR HEALTHCARE PROVIDER FOR SUGGESTED BASAL RATE ADJUSTMENTS DURING SICK DAYS. CHECK YOUR BLOOD GLUCOSE EVERY 2 HOURS AND KEEP CAREFUL RECORDS OF RESULTS. CHECK FOR KETONES WHEN BLOOD GLUCOSE IS 250 MG/DL OR HIGHER, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES FOR TAKING ADDITIONAL INSULIN ON SICK DAYS, AND DRINK PLENTY OF NONCAFFEINATED FLUIDS TO PREVENT DEHYDRATION. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU HAVE PERSISTENT NAUSEA, VOMITING FOR MORE THAN 2 HOURS, HIGH BLOOD GLUCOSE OR KETONES THAT STAY HIGH EVEN THOUGH YOU TAKE EXTRA INSULIN OR LOW BLOOD GLUCOSE WITH NAUSEA AND VOMITING."

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE HAD BEEN ADMITTED TO THE HOSP FOR A STOMACH VIRUS AND CAUSED DIABETIC KETOACIDOSIS. AT THE TIME OF HER CALL SHE WAS OUT OF THE HOSPITAL, FEELING BETTER AND ACTIVATING A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97264 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L50009

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization