BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7567364 · Received June 4, 2018

    Report

    Report Number
    3004464228-2018-03344
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. ADHESIVE PROPERTIES PRIOR TO USE COULD NOT BE DETERMINED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA TO FAIL TO INSERT CORRECTLY OR THE PUMP TO FAIL TO DELIVER INSULIN WAS FOUND. LOT NUMBER CHANGED FROM UNAVAILABLE TO L43510. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 06/01/2019. SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 0921343. DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 12/01/2017.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PATIENT REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. MYLIFE OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE MODEL: ENT450 14518-5C-AW REV E 03/16 USING THE POD 5 / PAGE 42 WARNING: CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHERE AS MAY INDICATE THE CANNULA HAS DISLODGED. 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.

    Description of Event or Problem · 1

    (B)(6). HE WAS NOT FEELING WELL AND UPON DEACTIVATION HE NOTICED THE CANNULA WAS OUT OF THE SKIN. THE PATIENT WAS ABLE TO ACTIVATE A NEW POD. HE ALSO NOTICED THE ADHESIVE PAD WAS COMING LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410211 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810 L43510

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR