BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 7722155 · Received July 26, 2018

    Report

    Report Number
    3004464228-2018-04728
    Event Type
    Injury
    Date Received
    July 26, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 18, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED; THEREFORE, NO LOT RELEASE RECORDS WERE REVIEWED. MYLIFE OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 14518-5C-AW REV E 03/16, CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96: WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE CHAPTER 9, LIVING WITH DIABETES), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIS BLOOD GLUCOSE HISTORY IS AS FOLLOWS: TIME BG (MMOL/L)(MG/DL): 20:19 13.7 247, 22:15 22.7 409. THERE WERE SEVERAL CORRECTION BOLUSES (EXACT AMOUNT WAS NOT PROVIDED) ALTHOUGH THE BOLUSES DID NOT LOWER THE PATIENT'S BG LEVELS. HE WAS NOT FEELING WELL AND WAS VOMITING SO HE DECIDED TO GO TO THE HOSPITAL. ON (B)(6) 2018: 00:32 26.9 485, 2:22 27.8 501, 3:59 19.4 350, 6:26 15.1 272, 8:22 11.9 AND 19.1 214 AND 344, 16:21 10.4 187. AT THIS POINT, THE CUSTOMER GOT A NEW POD AND WAS SENT HOME. AT 21:51 10.8 195, 23:48 8.8 159. THE POD WAS WORN BETWEEN 24 AND 36 HOURS ON THE ARM. AT THE HOSPITAL THEY PLACED HER ON AN INTRAVENOUS THERAPY OF INSULIN AND FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566220 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization