BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8663320 · Received June 3, 2019

    Report

    Report Number
    3004464228-2019-04817
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED AND RECEIVED WITH THE CANNULA ASSEMBLY DEPLOYED. INSPECTION OF THE FLUID PATH FOUND THE EXPOSED PORTION OF THE SOFT CANNULA TO BE BENT. ALTHOUGH THIS DAMAGE WAS OBSERVED, IT CANNOT BE DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. INSPECTION OF THE NEEDLE MECHANISM ASSEMBLY FOUND NO EVIDENCE THAT WOULD CONTRIBUTE TO A NEEDLE MECHANISM FAILURE; A ROOT CAUSE COULD NOT BE DETERMINED. NO OTHER DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE AND BENT CANNULA, OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: CAT45E/CAT45F. 15546-AW REV D 06/2016. USING THE POD 5 / PAGE 54. WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. YOU SHOULD CHECK YOUR BLOOD GLUCOSE 1.5 TO 2 HOURS AFTER EACH POD CHANGE AND CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHERE AS MAY INDICATE THE CANNULA HAS DISLODGED. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 98. 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 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

    IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: (B)(6). THE POD WAS DEACTIVATED AND IT WAS NOTICED THE CANNULA WAS BENT. THE PATIENT FEELS THAT THE NEEDLE DID NOT DEPLOY THE CANNULA PROPERLY. HYPERGLYCEMIA TREATED BY PATIENT WITH A MANUAL INJECTION WITH AN INSULIN PEN AND DRANK A LOT OF WATER. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457627 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L44292

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR