BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5952171 · Received September 15, 2016

    Report

    Report Number
    2531779-2016-25412
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Report Date
    August 18, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100211
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DATE OF SUBMISSION (B)(4) 2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2017 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX SHOWED CALL SERVICE 208 CONTINUOUS GLUCOSE MONITORING GLUCOSE BELOW USER LIMIT WARNINGS. THE USER SETTINGS SHOWED A CONTINUOUS GLUCOSE MONITORING LOW LIMIT ALERT WAS ENABLED AND SET TO 90MG/DL WITH A 60 MINUTE SNOOZE TIME. THE TEST TRANSMITTER PAIRED WITH THE PUMP CORRECTLY. A BLOOD GLUCOSE CALIBRATION OF 120MG/DL WAS ACCEPTED IN BOTH ATTEMPTS WITHIN 2 HOURS. THE PUMP AND TRANSMITTER RAN OVERNIGHT WITH A STEADY READING OF 115MG/DL WITHIN +/- 20%. NO ALARMS OCCURRED DURING THE INVESTIGATION. A TEST CALL SERVICE 208 WARNING WAS SIMULATED WITH 100MG/DL AS THE THRESHOLD AND WITH A 30 MINUTE SNOOZE TIME. THE PUMP GAVE THE APPROPRIATE CALL SERVICE 208 WARNING WITH AUDITORY AND VIBRATORY ALARMS. THE PUMP GAVE ANOTHER CALL SERVICE 208 WARNING 30 MINUTES PAST THE FIRST CALL SERVICE WARNING WAS CONFIRMED. THE INACCURATE SNOOZE TIME COMPLAINT WAS UNABLE TO BE 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BG BELOW LIMIT ALARM WAS NOT WORKING PROPERLY. IT WAS NOTED THAT THE USER HAD A RECEIVED A BG BELOW LIMIT ALERT AT 1:30 A.M. BUT WHEN THE TREND GRAPH CONTINUED TO SHOW THAT THE READINGS WERE STILL BELOW THE LIMIT AFTER 30 MINUTES, THE BG BELOW LIMIT ALERT DID NOT RE-ALERT. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN THE USER TO MISS THEIR BLOOD GLUCOSE (BG) TRENDING AND FAIL TO REACT TO ANY POTENTIAL BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603909 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100211

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR