BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8167289 · Received December 14, 2018

    Report

    Report Number
    2531779-2018-20675
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Report Date
    December 13, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #2: DATE OF SUBMISSION 09-APR-2019. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04-APR-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BLACK BOX VERIFIED EAW162 ¿LOSS OF PRIME EVENTS¿ ON (B)(6) 2018 WITH LOW NON-ZERO FORCE. INVESTIGATION TESTING WAS UNABLE TO DUPLICATE ¿EAW 162¿ LOSS OF PRIME DURING BASAL DURATION TESTING THE FORCE SENSOR CALIBRATION TEST CONFIRMED THE FORCE SENSOR IS WITHIN SPEC. NO CAPS WERE RETURNED FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PRODUCT PREVIOUSLY REPORTED AS UNKNOWN. THE CORRECT PRODUCT IS THE VIBE INSULIN PUMP. BRAND NAME: ANIMAS VIBE. COMMON DEVICE NAME: INSULIN INFUSION PUMP. MODEL #: ANIMAS VIBE INSULIN PUMP. SERIAL NUMBER: (B)(4). PMA 510K# P130007.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP REPEATEDLY EMITTED LOSS OF PRIME WARNINGS DESPITE CARTRIDGE CHANGES. 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 A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002990 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR