BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2220179 · Received August 15, 2011

    Report

    Report Number
    3004464228-2011-00417
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND NO EVIDENCE OF ANY MFG DEFECT WAS DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 5 UNITS OF INSULIN IN SIZE, WAS FOUND IN THE DEVICE'S INSULIN RESERVOIR. THIS TYPICALLY OCCURS DUE TO THE CUSTOMER INJECTING AIR DURING THE FILL PROCESS, RATHER THAN A MFG PROCESS ISSUE OR PRODUCT DEFECT. 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 TO, "NEVER INJECT AIR INTO THE FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY." INTERRUPTED INSULIN DELIVERY HAS THE POTENTIAL TO RESULT IN HIGH BLOOD GLUCOSE LEVELS. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO DETERMINE IF EDUCATION AND TRAINING RELATED TO THIS TOPIC CAN BE IMPROVED. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WENT TO BED AT 11:14PM WITH A BLOOD GLUCOSE (BG) OF 120MG/DL AND WOKE UP AT 6:20AM WITH A BG OF 185MG/DL. ALTHOUGH THIS IS STILL WITHIN THE "NORMAL" BG RANGE (LESS THAN 250MG/DL) HE STATED THAT HE "HAS NOT WOKEN UP TO A HIGH LIKE THAT BEFORE." HE DID REPORT A BG OF 254MG/DL THE DAY BEFORE, BUT HE IS "LESS CONCERNED ABOUT THE HIGHS AND LOWS DURING THE DAY AND MORE CONCERNED ABOUT THE CLIMB IN HIS BG'S OVERNIGHT FROM 11:14PM TO 6:20PM." HE "BUMPED" THE POD BED AND WANTS TO MAKE SURE THE DEVICE IS FUNCTIONING PROPERLY. THE PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30470

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR