BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6120352 · Received November 22, 2016

    Report

    Report Number
    2531779-2016-31949
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100204
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND ALARM HISTORY SHOWED A CALL SERVICE ALARM ALERTING THE PATIENT OF A BLOOD GLUCOSE (BG) BELOW 55 MG/DL ON (B)(6) 2016 AT 09:47AM. THE PUMP WAS DELIVERING THE PROGRAMMED BASAL RATE UNTIL (B)(6) 2016 AT 10:02AM. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REFLECTED THE PROGRAMMED BASAL RATE. THE PUMP POWERED UP WITH AUDITORY AND VIBRATION TO THE ¿VERIFY¿ SCREEN. THE PUMP REFLECTED 24U AFTER A 24HR ON 1U/HR; THE PUMP DELIVERED WITHIN SPECIFICATION. A LOW BG WARNING AND BG BELOW 55 WARNING WERE SIMULATED DURING A CONTINUOUS GLUCOSE MONITORING (CGM) SESSION AND THE PUMP GAVE THE APPROPRIATE AUDIBLE AND VISIBLE LOW BG WARNINGS. THE PRODUCT PERFORMED WITHIN SPECIFICATIONS AND THE ORIGINAL COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. THE PUMP¿S COVER WAS REMOVED AND NO DAMAGE WAS OBSERVED. 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) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 40MG/DL WITH NO REPORTED SIGNS OR SYMPTOMS OF HYPOGLYCEMIA ASSOCIATED WITH THE PUMP¿S AUDIBLE TONES NOT FUNCTIONING. REPORTEDLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND REMAINED ON THE PUMP. THE REPORTER STATED THAT THE PUMP EMITTED A LOW BG WARNING DURING THE NIGHT BUT THE AUDIBLE SOUND WAS NOT FUNCTIONING, SO THE PATIENT DID NOT HEAR THE ALARM AND HAD A LOW BG. THE REPORTER CONFIRMED THAT THE PUMP¿S VIBRATORY FEATURES WERE FUNCTIONING. DURING TROUBLESHOOTING, IT WAS NOTED THAT THE PUMP¿S ALARM SETTINGS FOR AUDIBLE TONES AND VIBRATIONS WERE SET CORRECTLY. THE REPORTER FOLLOW-UP WITH ANIMAS ABOUT THIRTY MINUTES AFTER THE INITIAL CALL STATED THAT THE PUMP ALERTED AGAIN FOR LOW BG AND THE SOUND FUNCTIONED NORMALLY. THE REPORTER NOTED DURING FOLLOW UP THAT THE SOUND HAD NOT FUNCTIONED FOR SEVERAL DAYS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH THE PUMP¿S AUDIBLE TONES NOT FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771701 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100204

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening