BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3251812 · Received July 18, 2013

    Report

    Report Number
    3004464228-2013-00794
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 PATIENT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS GREATER THAN 13.9 MMOL/L (250 MG/DL) MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 13.9 MMOL/L (250 MG/DL), BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 13.9 MMOL/L (250 MG/DL), FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.," AND 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 KDA DEVELOPS."

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. PATIENT IS STABLE AND IN HOSPITAL WITH LOW RISK OF FURTHER COMPLICATIONS. THE PATIENT'S PARENTS FELT THE POD WAS NOT DELIVERING INSULIN, THOUGH THERE WERE NO ALARMS RECORDED. IN A FOLLOW UP CALL, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER'S BLOOD GLUCOSE STABILIZED AFTER A NEW POD WAS ACTIVATED AND SHE WAS THEN RELEASED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334014 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14350-2J L30982

    Patients

    Seq Age Sex Outcome Treatment
    1 113 YR