BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2992839 · Received February 28, 2013

    Report

    Report Number
    3004464228-2013-00173
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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 NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS NO PRODUCT LOT NUMBER WAS PROVIDED. THE OMNIPOD USER GUIDE WARNS, "IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT ADVISES, "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 "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4 - 6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS." IT ALSO ADVISED, "TO HANDLE SICK DAYS: TREAT THE UNDERLYING ILLNESS TO PROMOTE FASTER RECOVERY. EAT AS NORMALLY AS YOU CAN. ADJUST BOLUS DOSES, IF NECESSARY, TO MATCH CHANGES IN MEALS AND SNACKS, ALWAYS CONTINUE YOUR BASAL INSULIN, EVEN IF YOU ARE UNABLE OT EAT. CONTACT YOUR HEALTHCARE PROVIDER FOR SUGGESTED BASAL RATE ADJUSTMENT 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. DRINK PLENTY OF NONCAFFEINATED FLUIDS TO PREVENT DEHYDRATION."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS IN THE EMERGENCY ROOM OVERNIGHT. SHE WAS STILL WEARING THE POD WHEN SHE CALLED. SHE SAID THAT SHE HAD A "VERY BAD SICK DAY" AND BECAUSE SHE WAS NEW TO THE PRODUCT, SHE POSSIBLY HAD NOT MADE THE NECESSARY ADJUSTMENTS TO HER DIABETES TREATMENT. SHE BELIEVED THAT THIS MAY HAVE CAUSED HER TO HAVE DIABETIC KETOACIDOSIS, BUT THIS DIAGNOSIS WAS NOT CONFIRMED BY THE EMERGENCY ROOM PHYSICIAN. SHE ALSO WAS DEHYDRATED FROM VOMITING ALL DAY. SHE HAD SET UP HER TEMPORARY BASAL THE NIGHT BEFORE AND WAS BEING GIVEN INSULIN IN THE EMERGENCY ROOM. SHE CALLED FOR ASSISTANCE FOR CANCELING THE TEMPORARY BASAL BECAUSE THE EMERGENCY ROOM WAS STOPPING THE INSULIN THEY WERE GIVING HER. SHE WAS UNABLE TO GO THROUGH THE PDM FOR ALL OF HER HISTORY BUT STATED THAT AT 8:00 AM ON (B)(6) 2013, HER BLOOD GLUCOSE WAS 208 MG/DL, SO SHE CORRECTED WITH A 2.70 UNIT BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86969 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other