BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5297024 · Received December 15, 2015

    Report

    Report Number
    3004464228-2015-02654
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 26, 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 PARAMEDICS VISIT FOR HYPERGLYCEMIA AND HYPOGLYCEMIA. POD RECEIVED: WAS L41345 AND SEQUENCE 0330648. THE LOT/SEQUENCE NUMBER ON THE RETURNED PRODUCT DOES NOT CORRELATE WITH THE REPORTED COMPLAINT. THE RETURNED DEVICE WILL BE PROCESS PER THE REPORTED COMPLAINT, WITH NO TRACEABILITY. NO RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," AND IT ADVISES ¿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

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE (BG) REACHED 323MG/DL AND LOW OF 23MG/DL AFTER WEARING THE POD LONGER THAN 48 HOURS. EMS WAS CALLED; THE PATIENT WAS DIAGNOSE WITH LOW SUGAR AND WAS TREATED WITH AN IV, COOKIES, AND "TOOTHPASTE GEW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828138 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other