BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3172784 · Received May 31, 2013

    Report

    Report Number
    3004464228-2013-00539
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    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 DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "THE CODE NUMBER ON THE SCREEN SHOULD MATCH THE CODE NUMBER ON THE SIDE OF YOUR TEST STRIP VIAL. THEY MUST ALWAYS MATCH OR YOUR RESULTS WILL BE INACCURATE," 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 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 REPORTED THAT SHE ACTIVATED THE DEVICE IN THE LATE AFTERNOON ON (B)(6) AND THAT HER BLOOD GLUCOSE WAS IN RANGE AT THAT TIME AND ALSO WHEN SHE WENT TO BED THAT NIGHT (NO EXACT MEASUREMENTS REPORTED). AT 4:00 AM THE NEXT MORNING HER CONTINUOUS GLUCOSE MONITOR ALERTED HER THAT HER BG WAS RISING. AT 5:00 AM SHE TOOK A 0.60 UNIT BOLUS TO CORRECT BG OF 173 MG/DL. SHE STATED THAT AT 6:10 AM HER BG READ 207 MG/DL WITH THE PDM SET TO TEST STRIP CALIBRATION CODE 28, SO SHE CHANGED THE CODE TO 16 AND GOT A RESULT OF 203 MG/DL. SHE DID NOT SPECIFY WHAT TEST STRIP CALIBRATION CODE APPEARED ON THE VIAL. AT 6:15 AM SHE WAS HAVING 16 GRAMS OF CARBOHYDRATE AND TOOK A 2.25 UNIT MEAL BOLUS. AT 7:09 AM HER BG MEASURED 309 MG/DL AND SHE DEACTIVATED THE POD. THE CANNULA APPEARED TO BE BENT WHEN IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241816 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40194

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR