BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10122722 · Received June 5, 2020

    Report

    Report Number
    3004464228-2020-08451
    Event Type
    Death
    Date Received
    June 5, 2020
    Date of Event
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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. UPDATED PER NEW INFORMATION PROVIDED ON 6/30/2020 DATE OF DEATH CHANGED FROM BLANK TO (B)(6) 2019. LOT NO CHANGED FROM BLANK TO L43948. SERIAL NO CHANGED FROM BLANK TO (B)(6). EXPIRATION DATE CHANGED FROM BLANK TO 12/7/2019. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). DEVICE MFG DATE CHANGED FROM BLANK TO 6/7/2018. EVALUATION CODES ADDED 1849 FATIGUE AND 1802 DEATH FOR PATIENT CODES AS WELL FOR CONCLUSIONS CODE 11 CONCLUSION NOT YET AVAILABLE. ADDTL MFG NARRATIVE WAS MODIFIED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO PRODUCT MALFUNCTION WAS ALLEGED. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO LOT RELEASE RECORDS WERE REVIEWED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: CAT45E/CAT45F, 15546-AW REV D 06/2016. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 98. 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 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 119: WARNING: IF LEFT UNTREATED, DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, AND EVENTUALLY DEATH. 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 PASSED AWAY AT THE HOSPITAL, DUE TO DIABETIC KETOACIDOSIS (DKA) WHILE USING THE OMNIPOD SYSTEM. NO OTHER INFORMATION OR DETAILS WERE PROVIDED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586419 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L43948

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H