BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 4751761 · Received May 6, 2015

    Report

    Report Number
    2531779-2015-15117
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 5, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWED THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2015 AT 15:09 AND MANUALLY RESUMED AT 19:33. A REVIEW OF THE TOTAL DAILY DOSES CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL AND BOLUS DELIVERIES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. THERE WERE NO ERRORS, ALARMS OR WARNINGS DURING THE 24HR DURATION TESTING. THE ORIGINAL COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2015, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) AS HIGH AS 22 MMOL/L WITH LARGE KETONES, NAUSEA, AND VOMITING ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. THE REPORTER STATED THAT THE PATIENT¿S BG LEVELS STARTED TO RISE ON (B)(6) 2015 AND THE PATIENT WAS TREATED WITH INSULIN VIA THEIR PUMP. REPORTEDLY, THE PATIENT¿S BG WAS 19 MMOL/L AND THEY INCREASED THEIR TEMPORARY BASAL RATE TO +150%; HOWEVER, THEIR BG CONTINUED TO RISE TO 20 MMOL/L AND KETONES WERE 0.1, SO THE PATIENT INCREASED THEIR TEMPORARY BASAL RATE AGAIN TO +200%. IT WAS REPORTED THAT AT 1:00AM ON (B)(6) 2015, THE PATIENT¿S KETONES WERE 6.1 AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS. THE REPORTER STATED THAT THE PATIENT FELT SICK AND WAS VOMITING AND WAS TREATED WITH IV FLUIDS, DEXTROSE AND INSULIN. ON (B)(6) 2015, THE PATIENT¿S BG WAS DOWN TO 4-5 MMOL/L, SO THE PATIENT HAD TOAST AND WAS CONNECTED BACK TO THE PUMP FOR A BOLUS. TWO HOURS LATER THE PATIENT¿S BG HAD RISEN TO 22 MMOL/L AGAIN. THE PATIENT CHANGED SITES AND ADDED A TEMPORARY BASAL RATE AND THE BG RESOLVED TO 4-5 MMOL/L AGAIN. REPORTEDLY, THE PATIENT¿S BG CONTINUED TO RISE TO 15 MMOL/L ONCE BACK AT HOME; THE PATIENT WAS TREATED WITH A CORRECTION DOSE VIA PEN. IT WAS REPORTED THAT THE PATIENT¿S BG DID DROP ONCE THEY USED NEW INSULIN IN THE PUMP. AT THE TIME OF THE CALL THE PATIENT REMAINED ON THE INSULIN PUMP FOR BASAL DELIVERY AND WAS RECEIVING BOLUSES VIA INJECTION. IT WAS REPORTED THAT THERE WAS NO OTHER ILLNESS, NO AIR BUBBLES IN THE CARTRIDGE AND THE CANNULA¿S LOOKED FINE. THE PUMP WAS PRIMED AND INSULIN WAS SEEN COMING OUT. IT WAS REPORTED THAT THE TIME AND DATE WERE CORRECT, THE BASAL SETTINGS WERE CORRECT AND USING THE CORRECT PROGRAM AND THE PUMP DELIVERED AS PROGRAMMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA BECAUSE OF AN INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297869 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R