BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 8821480 · Received July 24, 2019

    Report

    Report Number
    3004464228-2019-06716
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 8, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K180045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS DID NOT OBSERVE ANY ISSUES THAT WOULD CAUSE THE CANNULA TO IMPROPERLY INSERT INTO THE INFUSION SITE. THE DEVICE WAS DOWNLOADED AND AN ALARM WAS OBSERVED IN THE DATA. INVESTIGATION RESULTS DID NOT OBSERVE ANY ISSUES THAT WOULD RESULT IN THE ALARM GENERATING. THE REPORTED EVENTS COULD NOT BE DETERMINED.THE PRODUCT WAS RETURNED WITH A DIFFERENT SEQUENCE NUMBER THAN WAS REPORTED AND NOTED ON THE INITIAL MDR. CORRECTION TO : SEQUENCE NUMBER CHANGED FROM 002735 TO 0027035. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: 18320. 18296-ENG-AW REV B 06/18. CHANGING YOUR POD. CHAPTER 3 / PAGE 49. WARNINGS: 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 THAT THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THAT THE CANNULA HAS DISLODGED. BLOOD GLUCOSE READINGS. CHAPTER 4 / PAGE 56. WARNINGS: BLOOD GLUCOSE READINGS BELOW 70 MG/DL MAY INDICATE HYPOGLYCEMIA (LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 250 MG/DL MAY INDICATE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER'S SUGGESTIONS FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED INTO THE 300 MG/DL RANGE WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ARM. FATHER STATED THAT THE CANNULA WAS NOT DEPLOYED AS DEEP UNDERNEATH THE SKIN AS OTHER PODS AND THAT THIS MAY HAVE BEEN THE REASON WHY THE PATIENT WAS HAVING HIGHER BG LEVELS. FOR TREATMENT, FATHER STATES THAT THEY DID NOT GIVE ANYTHING EXTRA TO DETER THE HIGH BG. PATIENT'S FATHER STATED THAT THEY DID ATTEMPT TO ADMINISTER CORRECTION BOLUS DOSES BUT THE PATIENT WAS NOT RESPONDING TO IT. THE CORRECTION DOSE IS USUALLY 0.30-0.50 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614021 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C10181811 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR