BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221244 · Received August 17, 2011

    Report

    Report Number
    3004464228-2011-00431
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL, WE ARE THEREFORE, UNABLE TO ASSESS WHETHER THE DEVICE HAD ANY MALFUNCTION OR MFG DEFECT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS. WE DO NOT KNOW THE CUSTOMER'S SPECIFIC PDM SETTINGS (I.E., BASAL RATE, BOLUS DOSES) TO MAKE ANY ASSESSMENT OR BETTER UNDERSTAND THE AMOUNT OF INSULIN GOING INTO HER BODY, AT WHAT SPECIFIC TIMES THROUGHOUT THE DAY, AND WITH HOW MUCH FOOD AND CARBOHYDRATES. OMNIPOD'S USER GUIDE INSTRUCTS USERS TO WORK WITH THEIR HCP INITIALLY TO PROPERLY INPUT THE PDM SETTINGS THAT ARE UNIQUE TO EACH INDIVIDUAL, AND TO WORK WITH ONE'S HCP ANYTIME THEREAFTER WHEN CHANGES NEED TO BE MADE. THE LOT QUALIFICATIONS CANNOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER'S MOM CALLED TO REPORT A PDM ERROR, WHILE DISCUSSING THIS, SHE STATED THAT HER DAUGHTER HAS BEEN "PASSING OUT MORE FREQUENTLY NOW WITHIN THE LAST 2 MONTHS." FOR EXAMPLE, SHE PASSED OUT TODAY "5 MINUTES AFTER TREATING A MEAL BOLUS". "SHE FELT LIKE SHE WAS GOING TO VOMIT, [AND] AS SOON AS SHE MADE IT TO THE BATHROOM SHE PASSED OUT ON THE FLOOR." THE CUSTOMER WAS TAKEN TO HER REGULAR PEDIATRIC ENDOCRINOLOGIST AND HAD BLOOD WORK DONE. THE DAUGHTER HAD A BLOOD GLUCOSE OF 125 MG/DL - THE MOM "DIDN'T THINK SHE WAS LOW, BUT IT COULD BE A POSSIBILITY THAT SHE WAS COMING DOWN AND [THEY] GAVE MORE INSULIN ON TOP OF THAT." THE MOTHER INDICATED THIS WAS NOT THE FIRST TIME SHE HAD PASSED OUT FOLLOWING A BOLUS DOSE OF INSULIN, BUT THAT IT HAS HAPPENED SEVERAL TIMES IN THE LAST TWO MONTHS SO THEY WERE WONDERING IF THE POD WAS DELIVERING TOO MUCH INSULIN. THE MOTHER ALSO INDICATED THAT THE CUSTOMER IS GOING THROUGH PUBERTY AND HER PEDIATRIC ENDOCRINOLOGIST HAS BEEN CHANGING SOME OF HER SETTINGS. "ABOUT TWO MONTHS PRIOR TO THE DAY OF THE CALL, THE CUSTOMER'S ENDOCRINOLOGIST HAD MADE MORE CHANGES TO SOME SETTINGS." THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other