BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8989579 · Received September 11, 2019

    Report

    Report Number
    3004464228-2019-08631
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 9, 2019
    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 RETURNED DEVICE WAS EVALUATED AND IT WAS FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY INTERNAL DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. A CRACK WAS FOUND ON THE OUTER HOUSING. IT COULD NOT BE DETERMINED WHEN THE CRACK OCCURRED. INSPECTION OF THE DEVICE ALONG WITH THE DATA SUGGEST THAT THE CRACKS HAD NO EFFECT ON THE DEVICE'S FUNCTIONALITY.D4 - MODEL NO CHANGED FROM 14810 TO 19191. D4 - LOT NO CHANGED FROM BLANK TO L44772. D4 - CATALOG NO CHANGED FROM ZXY425 TO ZXP425. D4 - EXPIRATION DATE CHANGED FROM BLANK TO 10/20/2020. D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM BLANK TO(B)(4). G5 - PMA/510(K) # CHANGED FROM K122953 TO K162296. H4 - DEVICE MFG DATE CHANGED FROM BLANK TO 4/20/2019.

    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. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: ENT450. 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36. 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 "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 THAT A PATIENT WAS HOSPITALIZED FOR 3 DAYS, DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS OF 433 MG/DL AND KETONES OF 7.0 WHILE WEARING THE POD ON THE ARM BETWEEN 4 AND 24 HOURS. THE PATIENT TRIED CORRECTING WITH THE POD BUT THE BG LEVELS DID NOT DECREASE. AT THE HOSPITAL, THE PATIENT WAS TREATED WITH AN INTRAVENOUS (IV) THERAPY DRIP AND INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787193 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44772

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization