BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8565177 · Received April 30, 2019

    Report

    Report Number
    3004464228-2019-03657
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 21, 2019
    Report Date
    April 24, 2019
    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. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: ENT450, 17845-5C-AW REV A 10/17; CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36. WARNINGS: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNINGS: 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 "LIVING WITH DIABETES" ON PAGE 117), 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

    IT WAS REPORTED THE PATIENT HAD TO BE HOSPITALIZED FOR 3 DAYS DUE TO BLOOD GLUCOSE READING AT 22 MMOL/L (396 MG/DL) AFTER WEARING THE POD LONGER THAN 48 HOURS ON THE HIP/BUTTOCKS. HE ALSO FELT PRESSURE IN HIS CHEST. AT THE HOSPITAL THEY TREATED HIM WITH A MANUAL INJECTION WITH AN INSULIN PEN AND LATER THEY PLACED HIM ON AN INTRAVENOUS THERAPY OF INSULIN. THE PATIENT¿S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: TIME, BG (MMOL/L) (MG/DL): 21/04 22:00, 17.2, 310; 22/04 00:48, 18.1, 326; 22/04 09:28, 19.5, 351; 22/04 14:11, 15.8, 285; 23/04 00:49, 11.2, 202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360370 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44420 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization