BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1070987 · Received July 3, 2008

    Report

    Report Number
    3004464228-2008-00130
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 8, 2008
    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 EVALUATION INDICATES THAT A RETAINER ALLOWED A COMPONENT TO MOVE RESULTING IN DAMAGE WHICH PREVENTED THE PLUNGER FROM ADVANCING. THE USER WOULD HAVE BEEN AWARE OF A PROBLEM DURING THE FILL PROCESS. THERE IS RESISTANCE FELT IN FILLING THE POD WITH INSULIN AND A DISTINCT "CRACKLING" NOISE RESULTING FROM STRIPPING THE THREADS OF THE COMPONENT WHEN OVER-PRESSURISED. THE OMNIPOD USER GUIDE STATES: "WARNING: NEVER USE A POD IF, DURING FILL, YOU DETECT ANY CRACKLING NOISE OR RESISTANCE WHILE DEPRESSING THE PLUNGER OF THE FILL SYRINGE. USING A POD WITH THESE CONDITIONS COULD RESULT IN UNDER-DELIVER OF INSULIN." THE USER IS ALSO INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    A BABYSITTER CALLED TO SEEK HELP WITH A USERS HIGH BG'S. THE POD WAS WELL PLACED ON UPPER ARM AND THERE WAS NO INDICATION OF BLOOD OR A BENT/TOM CANNULA. SHE INDICATED THAT THE CHILD'S BG'S FLUCTUATED AS HIGH AS 380 DURING USE OF THIS POD. SHE WAS ADVISED TO CHANGE THE POD. SHE CALLED THE PARENTS AND SOUGHT MEDICAL ADVICE OVER THE PHONE. A FOLLOW-UP WAS MADE WITH THE CALLER AT 11:30P AND USER WAS STABLE. THE PARENTS HAD OPTED TO USE MANUAL INJECTIONS UNTIL THEY ARRIVED FROM OUT OF TOWN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11649

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention