BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3830374 · Received May 13, 2014

    Report

    Report Number
    3004464228-2014-00653
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    January 10, 2014
    Report Date
    May 3, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND NO EVIDENCE OF ANY MFG DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 30+ UNITS OF INSULIN IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. AS THERE WAS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE RESIDUAL INSULIN, THIS WAS MOST LIKELY INTRODUCED DURING THE FILL PROCESS. USE ERROR IS THEREFORE DETERMINED TO BE THE ROOT CAUSE OF THE HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE AND WARNS TO, WARNS "NEVER INJECT AIR INTO THE FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY," "FAILURE TO EXPEL AIR BUBBLES FROM THE SYRINGE MAY RESULT IN INTERRUPTED INSULIN DELIVERY," "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN--USUALLY WITH AN INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTION ON HANDLING INTERRUPTED INSULIN DELIVERY," AND " TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU DO HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL AT 9:55 AM WAS 238 MG/DL. AT 12:20 PM IT ROSE TO 289 MG/DL. AT 1:51 PM, HER BG WERE AT 322 MG/DL SO SHE REMOVED THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285396 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40756

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR