BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2861778 · Received November 6, 2012

    Report

    Report Number
    3004464228-2012-00560
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    September 16, 2012
    Report Date
    October 8, 2012
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    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 10 UNITS OF INSULIN IN SIZE, WAS FOUND IN THE RESERVOIR WITH ONLY ONE INSERTION MARK IN THE FILL SEPTUM. THIS INDICATES THAT THE USER DID NOT REMOVE ANY RESIDUAL INSULIN AND THAT THE AIR BUBBLE WAS FROM THE ORIGINAL FILLING OF THE POD. USER ERROR IS CONFIRMED AS HAVING CAUSED THE POD TO FAIL TO PERFORM ITS ESSENTIAL FUNCTION. THE OMNIPOD'S USER GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE AND WARNS, "NEVER INJECT AIR INTO FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY," "FAILURE TO EXPEL AIR BUBBLES FROM THE FILL SYRINGE MAY RESULT IN INTERRUPTED INSULIN DELIVERY," AND "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 IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. 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 INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY." PRODUCT LOT QUALIFICATION RECORDS WERE REVIEWED AND FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA. AN INVESTIGATION WAS INITIATED INTO THIS ISSUE. IT HAS BEEN OBSERVED THAT THE COMPLAINT RATE FOR HIGH BLOOD GLUCOSE ROOT CAUSE TO USER ERROR AIR IN POD HAS BEEN SIGNIFICANTLY REDUCED AND IS CURRENTLY RUNNING AT ACCEPTABLE LEVELS. INSULET WILL CONTINUE TO MONITOR THESE COMPLAINT RATES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2012 AT 7:23 AM, AFTER LESS THAN A DAY WEARING THE SUBJECT DEVICE, HER BLOOD GLUCOSE MEASURED 239 MG/DL; A 2.7 UNIT OF BOLUS OF INSULIN WAS GIVEN. AT 7:50 AM, BG: 226 MG/DL; SHE AT ABOUT 40 GRAMS OF CARBOHYDRATE AND TOOK AN ADD'L 4.45 UNITS OF BOLUS. AT 11:35 AM WITH BG OF 256 MG/DL, SHE TOOK A 3.15 UNIT OF BOLUS AND ANOTHER OF 2.65 UNITS AT 12:20 PM. AT 1:21 PM, BG 322 MG/DL; A 3.45 UNITS OF BOLUS WAS GIVEN. HER BG WAS 320 MG/DL AT 1:40 PM AND 300 MG/DL AT 2:13 PM. AT THAT TIME THE POD WAS DEACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30919

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR