BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 4775774 · Received May 15, 2015

    Report

    Report Number
    2531779-2015-16257
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 14, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2015 THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA. THE PATIENT REPORTEDLY HAD AN UNSPECIFIED LOW BLOOD GLUCOSE (BG) AROUND 3PM ON (B)(6) 2015 AND FELT TIRED. THE PATIENT REPORTEDLY AWOKE AROUND 9PM AND AN AMBULANCE WAS CONTACTED. THE PATIENT¿S BG AT THE TIME OF ADMISSION TO THE HOSPITAL WAS REPORTEDLY 20.1MMOL/L AT 11PM AND THE PATIENT WAS REPORTEDLY TREATED WITH A BOLUS. THE PATIENT¿S BOLUS RATE WAS REPORTEDLY INCREASED BY 10 PERCENT UPON ADMISSION TO THE HOSPITAL. THE PATIENT¿S BG REPORTEDLY WENT LOW AND REMAINED LOW OVERNIGHT, BETWEEN 4 AND 9MMOL/L AND THE PATIENT WAS MONITORED AND TREATED WITH ORAL CARBOHYDRATES. THE PATIENT¿S BG AT 8AM THE FOLLOWING MORNING WAS REPORTEDLY 12.1MMOL/L AND ROSE TO 18MMOL/L BY 10:30AM. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP AND PUT ON INSULIN PENS, AND THE PATIENT¿S BG WAS REPORTEDLY STABILIZING. A REVIEW OF THE PATIENT¿S DIASEND REPORT INDICATED THAT THE PATIENT HAD BEEN EXPERIENCING REGULAR HYPOGLYCEMIC INCIDENTS OVER THE PAST MONTH. THE PATIENT ADMITTED TO TREATING LOW BG WITH LARGE QUANTITIES OF ORAL CARBOHYDRATES AND GIVING LARGE BOLUSES FOR THE CARBOHYDRATES WHILE BG WAS STILL LOW. THE PATIENT¿S BG HAD REPORTEDLY BEEN AS LOW AS 1.9MMOL/L ON AN UNSPECIFIED DATE. THE PATIENT ALSO HAD REPORTEDLY COME OFF ANTIBIOTICS THE WEEK PRIOR TO THE (B)(6) 2015 INCIDENT AND HAD BECOME UNWELL, AND HAD ALSO EXPERIENCED A COUPLE OF UNSPECIFIED LOW BGS DURING THE PREVIOUS WEEK. TROUBLESHOOTING DID NOT FIND ANY PUMP DEFECTS. THE PATIENT WAS ADVISED ON HOW TO PROPERLY TREAT LOW BGS AND RESUMED INSULIN PUMP THERAPY. ALTHOUGH THE ALLEGED LOW BGS WERE DETERMINED TO BE RELATED TO DIABETES MANAGEMENT FACTORS, IT IS UNCLEAR AT THIS TIME IF THE 10 PERCENT INCREASE IN BASAL RATE AT THE TIME OF HOSPITAL ADMISSION WAS RELATED TO THE LOW BGS OVERNIGHT ON (B)(6) 2015. IT IS UNCLEAR WHY THE INCREASE IN BASAL RATES WAS MADE, AND IF THE PATIENT MADE THE CHANGES OR THE PATIENT¿S HEALTHCARE PROVIDER MADE THE CHANGES. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA POTENTIALLY ASSOCIATED WITH USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318703 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R