BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 3013482 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02878
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE ALARM HISTORY WAS REVIEWED AND NO ACTIVITY OUTSIDE NORMAL USE WAS OBSERVED. THERE WAS A LOW CARTRIDGE ALARM ON (B)(6) 2013 AND A CALL SERVICE ALARM ON (B)(6) 2013. DAILY BASAL INSULIN DELIVERIES CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE TOTAL DAILY DOSE HISTORY SHOWED A DRASTIC DROP OF TOTAL DAILY FROM ~37 UNITS TO 19 UNITS STARTING ON THE REPORTED COMPLAINT DATE ((B)(6) 2013). THE LAST BOLUS DELIVERY RECORDED IN BOLUS HISTORY WAS ON (B)(6) 2013 AT 8:56 P.M.; NO FURTHER BOLUS DELIVERIES WERE PERFORMED EVEN THOUGH BASAL DELIVERIES CONTINUED. THE PUMP POWERED ON NORMALLY AND PASSED THE 'EZ-PRIME' STEPS CORRECTLY. THE PUMP WAS EXERCISED FOR 24 HOURS, AND PASSED THE FLOW ACCURACY TEST. NO ALARMS OCCURRED DURING TESTING. THE PUMP WAS OBSERVED TO DELIVER TO SPECIFICATIONS. THE PUMP WAS OPENED AND INSPECTED. NO MOISTURE INGRESS WAS OBSERVED. NO INTERMITTENT CONDITION OR DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT OR THE POWER CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, SHE NOTICED THAT HER BLOOD GLUCOSE (BG) STARTED TO ELEVATE TO 19MMOL/L; SHE REPORTEDLY DEVELOPED A HEADACHE AND THEN LATER BECAME SICK. ON (B)(6) 2013, THE PATIENT REPORTEDLY WAS IN "DIABETIC KETOACIDOSIS (DKA) AND WAS HOSPITALIZED. IT WAS NOTED THAT UPON ADMISSION TO THE HOSPITAL, HER BLOOD GLUCOSE MEASUREMENT REPORTEDLY ELEVATED TO 32MMOL/L. THE PATIENT REPORTEDLY WAS REMOVED OFF THE PUMP AND WAS TREATED VIA INSULIN DRIP. THE PATIENT DENIED CHANGES IN DIET OR ACTIVITY. THERE WERE NO ISSUES NOTED WITH THE SITE/SET OR CARTRIDGE. THERE WERE REPORTEDLY NO ISSUES NOTED WITH PROGRAMMING OR SETTINGS ON THE PUMP. NO DELIVERY ISSUES WERE NOTED WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS NOT CLEAR WHAT CAUSED THE PATIENT'S BG EXCURSION OR WHETHER OR NOT THE PUMP WAS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116215 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R