BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3170132 · Received June 6, 2013

    Report

    Report Number
    3004464228-2013-00569
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INSULET CORP
    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 DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION WITH DIABETIC KETOACIDOSIS AND HYPERGLYCEMIA. NO LOT QUALIFICATIONS RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS "HIGH CHECK FOR KETONES!" READING AND FELL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA. IF YOU GET A "HIGH CHECK FOR KETONES!" READING, BUT HAVE NO SYMPTOMS OF HIGH BLOOD GLUCOSE, THEN RETEST WITH A NEW TEST STRIP ON YOUR FINGERS. IF YOU STILL GET A "HIGH CHECK FOR KETONES!" READING, PERFORM A CONTROL SOLUTION TEST TO ENSURE YOUR SYSTEM IS WORKING PROPERLY. IF THE SYSTEM IS WORKING PROPERLY, 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." IT ADVISES, "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."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6), HER BLOOD GLUCOSE RESULT WAS "HIGH" (>500 MG/DL), AND SHE WENT TO THE EMERGENCY ROOM. SHE STATED THAT SHE WAS ADMITTED WITH DIABETIC KETOACIDOSIS, AND HER BLOOD GLUCOSE RESULTS WAS 960 MG/DL. SHE WAS GIVEN INSULIN AND INTRAVENOUS FLUIDS AT THE HOSPITAL AND WAS DISCHARGED AFTER 3 DAYS. THE POD WAS DISCARDED. SHE STATED THAT ALTHOUGH SHE COULD NOT LOCATE THE EXPIRATION DATE ON THE INSULIN BOX, HER INSULIN WAS NOT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251971 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization