BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7617754 · Received June 19, 2018

    Report

    Report Number
    2531779-2018-11249
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Report Date
    June 15, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 13-JUL-2018 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA AND THE CONTINUOUS GLUCOSE MONITORING HISTORY (CGM) SHOWED ¿213/208¿ CGM GLUCOSE ABOVE/BELOW THE USER LIMIT WARNINGS. REVIEW OF THE USER SETTINGS SHOWED CGM HIGH AND LOW LIMITS ALERT WERE ENABLED AND SET TO 240 MG/DL AND 80 MG/DL. A TEST TRANSMITTER WAS PAIRED WITH THE PUMP CORRECTLY. BLOOD GLUCOSE CALIBRATION OF 120 MG/DL WAS ACCEPTED IN BOTH ATTEMPTS WITHIN 2 HOURS. THE PUMP AND THE TRANSMITTER WERE PAIRED AND EXERCISED FOR 24 HOURS WITHOUT ISSUE. A CALL SERVICE 213 WARNING WAS SIMULATED DURING THE INVESTIGATION AND THE PUMP GAVE THE APPROPRIATE AUDIO AND VISUAL WARNINGS. INVESTIGATION DID NOT DUPLICATE THE ALLEGED ¿ABSENCE OF CGM ALERTS.¿ UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED DURING THE INVESTIGATION. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN WAS NOTED TO BE DIM/DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (DUAL ALARM FAILURE) ISSUE. IT WAS ALLEGED THAT THERE WAS NO SOUND. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE IF THE AUDITORY AND VIBRATORY ALERTS ARE NOT FUNCTIONAL, THE USER MAY BE UNAWARE OF ALARMS OR WARNINGS, LEADING TO THE POTENTIAL FOR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458045 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR