BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3070594 · Received April 11, 2013

    Report

    Report Number
    3004464228-2013-00335
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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, DIABETIC KETOACIDOSIS AND HOSPITALIZATION. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER' AND IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH." IT ADVISES, "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" AND "HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE (NO MATTER HOW MILD). IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BG LEVEL TO CONFIRM."

    Description of Event or Problem · 1

    A HOSPITAL NURSE CALLED TO REPORT THAT A PT WAS IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS. THE PT'S HUSBAND THEN PROVIDED ADDITIONAL INFO. HE REPORTED THAT HIS WIFE'S BLOOD GLUCOSE RESULT HAD BEEN 20 MG/DL, AND SHE WAS DELIRIOUS AND NOT VERY RESPONSIVE. HE STATED THAT THEY TREATED THE HYPOGLYCEMIA, AND HER BLOOD GLUCOSE THEN SPIKED UP TO 480 MG/DL. HE SAID THAT THEY THEN ATTEMPTED TO GIVE HER A BOLUS, AND IT ROSE TO 575 MG/DL. SHE WAS NAUSEATED AND VOMITING BILE. HER BLOOD GLUCOSE WAS READING "HIGH" (>500 MG/DL) AND HE CONTACTED THE PARAMEDICS, WHO TOOK HER TO THE HOSPITAL IMMEDIATELY BY AMBULANCE. AT THE HOSPITAL, SHE WAS TREATED WITH AN INSULIN DRIP, WHICH LOWERED HER BLOOD GLUCOSE TO A NORMAL RANGE WITH NO KETONES PRESENT. SHE HAD BEEN IN THE HOSPITAL FOR 7 HOURS AT THE TIME OF THE CALL, AND THE DOCTORS STATED THAT SHE WOULD BE HOSPITALIZED UNTIL SHE WAS ABLE TO MANAGE HER BLOOD GLUCOSE LEVELS. THE HUSBAND STATED THAT HE DID NOT HAVE THE PDM AND COULD NOT PROVIDE ANY HISTORY OF BLOOD GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157082 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization