BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8703925 · Received June 17, 2019

    Report

    Report Number
    3004464228-2019-05304
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 9, 2019
    Report Date
    June 10, 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

    INVESTIGATION FOUND NO DEFECTS OR MANUFACTURING DEFICIENCIES THAT WOULD CONTRIBUTE TO A DISLODGING OF THE CANNULA OR A FAILURE OF THE POD TO DELIVER INSULIN. THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. ALTHOUGH NO DAMAGE WAS PRESENT, THE REPORTED EVENT COULD NOT BE DETERMINED. NO KINKS OR BENDS WERE IDENTIFIED ON THE EXPOSED PORTION OF THE CANNULA. FLUID PATH TESTING SHOWED THAT INSULIN WAS ABLE TO PASS OUT THE DISTAL TIP OF THE SOFT CANNULA. THE DEVICE DOWNLOAD DATA SHOWS NO INCREASE IN PULSE WIDTHS OR SIGNS OF STRUGGLE DURING THE RUN THAT WOULD INDICATE A FLUID PATH OCCLUSION. NO OTHER DEFECTS OR DEFICIENCIES WERE IDENTIFIED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE CANNULA HAD PULLED OUT OF THE INFUSION SITE. A DISLODGED CANNULA COULD INTERRUPT INSULIN DELIVERY AND MAY LEAD TO HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. 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 / PAGES 43-44: WARNING:  CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY. VERIFY THERE IS NO WETNESS OR SCENT OF INSULIN, WHERE AS MAY INDICATE THE CANNULA HAS DISLODGED. WARNING:  BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. 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 READ ¿HIGH¿ (> 27.8 MMOL/L) (> 500 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS ON THE ARM. UPON INSPECTION IT WAS NOTED THAT THE POD HAD DISLODGED FROM THE INFUSION SITE AND IT WAS FOUND IN BETWEEN TWO SWEATERS. THE PATIENT STATED HAVING DIFFICULTY FILLING THE POD DURING ACTIVATION AND THE CANNULA WAS NOTICED TO BE BENT AFTER REMOVAL. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499184 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L43856

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR