BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10088041 · Received May 26, 2020

    Report

    Report Number
    3004464228-2020-07574
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 25, 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

    THE POD WAS FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN.***PER NEW INFORMATION, THE FOLLOWING WERE CORRECTED*** D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L45167. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 3/29/2021. 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 9/29/2019.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED OVERNIGHT DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS OF 370 MG/DL AND KETONES OF 4.1, WHILE WEARING THE POD ON THE BACK BETWEEN 36 AND 48 HOURS. AT THE HOSPITAL, THE PATIENT WAS PLACED ON AN INSULIN DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552018 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45167

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R