BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3162097 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00534
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 1, 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 EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISES, "TO TREAT HYPOGLYCEMIA (LOW BLOOD GLUCOSE): ANY TIME YOUR BLOOD GLUCOSE IS LOW, TREAT IT IMMEDIATELY. CHECK IT EVERY 15 MINUTES WHILE YOU ARE TREATING, TO MAKE SURE YOU DON'T OVERTREAT THE CONDITION AND CAUSE BLOOD GLUCOSE LEVELS TO RISE TOO HIGH. IF BLOOD GLUCOSE IS BELOW 70 MG/DL, EAT OR DRINK 15 GRAMS OF FAST-ACTING CARBOHYDRATE, SUCH AS GLUCOSE TABLETS, JUICE, OR HARD CANDY. CHECK BLOOD GLUCOSE AGAIN AFTER 15 MINUTES. IF BLOOD GLUCOSE REMAINS LOW, TAKE ANOTHER 15 GRAMS OF CARBOHYDRATE. CONTACT YOUR HEALTHCARE PROVIDER AS NEEDED FOR GUIDANCE. REPEAT STEPS 2 AND 3 UNTIL BLOOD GLUCOSE IS WITHIN THE BG GOAL."

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT HE HAD HYPOGLYCEMIA WHILE WEARING A POD. HE REPORTED THAT ON (B)(6), HIS BLOOD GLUCOSE RESULT WAS 91 MG/DL AT 7:57 PM. HE CONSUMED 52 GRAMS OF CARBOHYDRATE AND GAVE HIMSELF A 12.75 U BOLUS. AT 9:04 PM, HIS RESULT WAS 28 MG/DL. HE STATED THAT HIS DAUGHTER ATTEMPTED TO REVERSE CORRECT. AT 09:17 PM, IT WAS 23 MG/DL, AND SHE CONTINUED TO ATTEMPT REVERSE CORRECTING. AT 9:22 PM, IT WAS 31 MG/DL AND THE PARAMEDICS WERE CALLED. HE PROVIDED THE FOLLOWING RESULTS: TIME: 9:26 PM, BLOOD GLUCOSE: 26 MG/DL; TIME: 9:32 PM, BLOOD GLUCOSE: 34 MG/DL; TIME: 9:39 PM, BLOOD GLUCOSE: 64 MG/DL. THE PARAMEDICS CAME TO HIS HOME TO STABILIZE HIM. HE WAS NOT TRANSPORTED TO THE HOSPITAL OR EMERGENCY ROOM. THE PATIENT WAS NOT SURE HOW HE WAS STABILIZED, BUT SAID THAT PRIOR TO THEM COMING, HIS DAUGHTER HAD GIVEN HIM 2 GLASSES OF JUICE, A GLASS OF SODA AND AN ICE CREAM SANDWICH, THEN A LITTLE LATER, SHE GAVE HIM SOME ECLAIRS. THE PARAMEDIC CHECKED THE PATIENT'S PDM AND SAID HE HAD BEEN GIVEN 29 U OF INSULIN. IT IS UNCLEAR WHETHER THE PATIENT WAS GIVEN AN INDIVIDUAL BOLUS OF 29 U OR IF THAT WAS FOR THE DAY, AS A REVIEW OF THE PDM SHOWED THE TOTAL BOLUS DELIVERY FOR (B)(6) WAS 29.50 U, WHICH INCLUDED THE 12.75 U BOLUS AT 7:57 PM. AT 10:21 PM, THE POD WAS DEACTIVATED. AT 10:46 PM, THE PATIENT'S BLOOD GLUCOSE RESULT WAS 154 MG/DL. HE DID NOT KNOW THERE THE POD WAS, SO HE WAS UNABLE TO PROVIDE THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237986 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other