BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7451982 · Received April 23, 2018

    Report

    Report Number
    3004464228-2018-02409
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 12, 2017
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE RUNNING A SIMULATED USE TEST ON THE DEVICE'S ORIGINAL BLOOD GLUCOSE (BG) METER BOARD, COMMUNICATION COULD NOT BE ESTABLISHED. AFTER REPLACING THE BG METER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), COMMUNICATION WAS ESTABLISHED AND THE BG READINGS WERE RETRIEVED AND FOUND TO BE WITHIN TOLERANCE. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICAL COMPONENT FAILURE ON THE BG METER PCBA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400; 14421-AW REV H 01/16. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 95 WARNING: ¿LOW¿ OR ¿HIGH¿ BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 81: YOU SHOULD PERFORM A CONTROL SOLUTION TEST WHEN YOU SUSPECT THAT YOUR METER OR TEST STRIPS ARE NOT WORKING PROPERLY, WHEN YOU THINK YOUR TEST RESULTS ARE NOT ACCURATE, OR IF YOUR TEST RESULTS ARE NOT CONSISTENT WITH HOW YOU FEEL. LIVING WITH DIABETES 9 / PAGES 108-109: KEEP AN EMERGENCY KIT WITH YOU AT ALL TIMES TO QUICKLY RESPOND TO ANY DIABETES EMERGENCY. THE KIT SHOULD INCLUDE: SEVERAL NEW, SEALED PODS, EXTRA NEW PDM BATTERIES (AT LEAST TWO AAA ALKALINE), A VIAL OF RAPID-ACTING U-100 INSULIN, SYRINGES FOR INJECTING INSULIN, INSTRUCTIONS FROM YOUR HEALTHCARE PROVIDER ABOUT HOW MUCH INSULIN TO INJECT IF DELIVERY FROM THE POD IS INTERRUPTED, BLOOD GLUCOSE TEST STRIPS, KETONE TEST STRIPS, LANCING DEVICE AND LANCETS, GLUCOSE TABLETS OR ANOTHER FAST-ACTING SOURCE OF CARBOHYDRATE, ALCOHOL PREP SWABS. ADVISED: WHEN PACKING FOR TRAVEL, TAKE MORE SUPPLIES THAN YOU THINK YOU¿LL NEED. BE SURE TO INCLUDE: DIABETES EMERGENCY KIT PACKED IN YOUR CARRY-ON LUGGAGE, ENOUGH PODS FOR YOUR TRIP, PLUS A BACKUP SUPPLY, EXTRA NEW PDM BATTERIES, ADDITIONAL BLOOD GLUCOSE METER, INSULIN SYRINGES OR PENS IN CASE YOU NEED INJECTIONS, SEVERAL VIALS OF INSULIN OR INSULIN CARTRIDGES IF YOU USE A PEN, GLUCAGON KIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S PERSONAL DIABETES MANAGER WAS NOT REGISTERING WHEN BLOOD GLUCOSE (BG) TEST STRIPS WERE INSERTED INTO THE DEVICE'S METER. WITH A BACKUP METER, PATIENT'S BG MEASURED 291MG/DL. THE DEVICE HAS SINCE BEEN RECEIVED AND INVESTIGATED. AN ELECTRICAL COMPONENT FAILURE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293752 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14500-5A L60319 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR