BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8069764 · Received November 14, 2018

    Report

    Report Number
    3004464228-2018-07859
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 8, 2018
    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 · 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. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO LOT RELEASE RECORDS WERE REVIEWED. 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE EITHER DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED HIGH BLOOD GLUCOSE LEVELS. CORRECTION: LOT NUMBER CHANGED FROM UNAVAILABLE TO L43876. SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO (B)(4). EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 11/13/2019. MODEL NO CHANGED FROM 14810 TO 19191. UNIQUE IDENTIFIER (UDI) # CHANGED FROM UNAVAILABLE TO (B)(4). PMA/510(K) # CHANGED FROM K122953 TO K162296. DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 05/13/2018.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAD TO BE HOSPITALIZED WITH BLOOD GLUCOSE READING GREATER THAN 400 MG/DL. AT THE HOSPITAL THEY PLACED HIM ON AN INTRAVENOUS DRIP. HE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908909 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L43876

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization