BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10169795 · Received June 18, 2020

    Report

    Report Number
    3004464228-2020-09390
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    June 15, 2020
    Report Date
    June 16, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K162296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ***PER NEW INFORMATION THE FOLLOWING WERE UPDATED*** D1 - BRAND NAME CHANGED FROM OMNIPOD INSULIN PUMP TO OMNIPOD INSULIN MANAGEMENT SYSTEM. D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L45344. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 6/10/2021. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). TO (B)(4). G5 - PMA/510(K) # CHANGED FROM K192659 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 12/10/2019.

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. INSPECTION OF THE CANNULA ASSEMBLY FOUND NO PROBLEMS WITH FLUID PASSING FREELY THROUGH THE COMPLETE FLUID PATH, THOUGH THE EXPOSED PORTION OF THE SOFT CANNULA WAS KINKED. IT COULD NOT BE DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. THE DOWNLOAD DATA DOES NOT CONTAIN ANY TIMEOUTS OR PULSE WIDTH INCREASES THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION, HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. 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. LIVING WITH DIABETES 9 / PAGE 121. WARNING: IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH. THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4¿6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS. FOR YOUR REFERENCE, INSULET MODIFIED OUR INTERNAL INVESTIGATION FINDING CODES EFFECTIVE 25 MAY 2020 AS PART OF AN EFFORT TO IMPROVE THE CLASSIFICATION OF FINDINGS TO IMPROVE THE POWER OF TRENDING DATA AND MAKE THE FINDINGS MORE INTUITIVE. THE NEW FINDINGS CODES WILL USE THE SYSTEM OF FINDING CATEGORY (E.G. HARDWARE COMPONENT), FOLLOWED BY THE AFFECTED COMPONENT (E.G. NEEDLE), FOLLOWED BY THE CONDITION (E.G. BENT). THEREFORE YOU MAY NOTICE FINDINGS THAT APPEAR TO BE NEW OR DIFFERENT BUT IN FACT ARE JUST RENAMED FOR IMPROVED DATA VALUE. INSULET WOULD BE HAPPY TO EXPLAIN ANY MAPPING OF THE OLD TO NEW FINDING CODES IF YOU HAVE ANY QUESTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS (DKA) AND HIGH BLOOD GLUCOSE (BG) LEVELS OF 498 MG/DL, WHILE WEARING THE POD ON THE ABDOMEN LONGER THAN 48 HOURS. AT THE HOSPITAL, THE PATIENT WAS PLACED ON AN INTRAVENOUS DRIP OF SALINE SOLUTION AND A MANUAL INSULIN INJECTION USING A PEN WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633815 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45344

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R