BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6303358 · Received February 6, 2017

    Report

    Report Number
    2531779-2017-02959
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    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 TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE REPORTER CONTACTED ANIMAS TO TROUBLESHOOT AN ELEVATED BLOOD GLUCOSE OF 20 MMOL/L AND WHILE ON THE PHONE WITH CUSTOMER TECHNICAL SUPPORT (CTS), THE PATIENT¿S BG DROPPED TO 1 MMOL/L AND AN AMBULANCE WAS CONTACTED. DURING TROUBLESHOOTING, THE PATIENT APPEARED TO BE CONFUSED AND WAS UNABLE TO PROVIDE CTS WITH ACCURATE INFORMATION. THE PATIENT¿S BG REPORTEDLY DROPPED DRASTICALLY DURING THE CALL AND AFTER DROPPING TO 6.6 MMOL/L, THE PATIENT REPORTEDLY TOOK GLUCOSE TABLETS. IT WAS UNCLEAR IF THE PATIENT TOOK 2 GLUCOSE TABLETS, OR 4. THE PATIENT¿S BG ROSE TO 13.9 MMOL APPROXIMATELY 40 MINUTES AFTER THE 6.6 MMOL/L BG READING, HOWEVER THE PATIENT¿S BG REPORTEDLY DROPPED TO 1 MMOL/L AT AN UNSPECIFIED TIME DURING THE CALL. EMERGENCY MEDICAL SERVICES WAS REPORTEDLY CONTACTED, AND PARAMEDICS REPORTEDLY TREATED THE PATIENT WITH INTRAVENOUS GLUCOSE AND INTRAVENOUS FLUIDS. CTS REVIEWED THE PRIME HISTORY WITH THE PARAMEDICS, AND IT WAS DETERMINED THAT THE PATIENT HAD PERFORMED SEVERAL PRIMES AND FILL CANNULA STEPS WHILE STILL ATTACHED TO THE INFUSION SET, RESULTING IN THE PATIENT RECEIVING 33.6 UNITS OF ADDITIONAL, UNINTENDED INSULIN. NO PUMP DEFECTS WERE FOUND DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED SEVERE HYPOGLYCEMIA ASSOCIATED WITH USE ERROR OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87290 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R