BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5297023 · Received December 15, 2015

    Report

    Report Number
    3004464228-2015-02653
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULET CORPORATION IS SUBMITTING THIS MDR THAT WAS PREVIOUSLY INCLUDED IN THE Q1 2015 ALTERNATIVE SUMMARY REPORT (ASR). THIS MDR IS BEING RE-SUBMITTED AFTER THE 30 DAY REQUIREMENT DUE TO ERRONEOUS INCLUSION IN Q1 2015 ASR. THIS ERROR WAS COMMUNICATED TO FDA ON JULY 31ST, 2015 WHEN WE SUBMITTED A REQUEST FOR PERMISSION TO SUBMIT A RETROSPECTIVE SUMMARY REPORT (RSR) UNDER 21 CFR PART 803.19. FDA DECLINED INSULET PARTICIPATION IN THE RSR PROGRAM IN A DECISION DATED AUGUST 26, 2015 AND EMAILED ON SEPTEMBER 3, 2015. AS A RESULT, INSULET IS COMMITTED TO COMPLETE THESE CORRECTIONS THROUGH THIS SUBMISSION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER REPORT THAT HER BLOOD GLUCOSE REACHED 25MMOL/L (450MG/DL) AFTER WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT WAS IN ICU OVER THE WEEKEND AND WENT INTO DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827660 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L41307

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization