BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 8454549 · Received March 26, 2019

    Report

    Report Number
    2531779-2019-02138
    Event Type
    Injury
    Date Received
    March 26, 2019
    Report Date
    March 25, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1: DATE OF SUBMISSION 23-APR-2019. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 17 -APR-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED USER'S PROGRAMMED BASAL RATES. THE PUMP HISTORY SHOWED THE PUMP WAS DELIVERING PROGRAMMED BASAL RATE UNTIL A CALL SERVICE 064-0008 ALARM AT 5:26PM ON 3/23/19. THERE WERE MULTIPLE CALL SERVICE 078-0008 ALARMS OBSERVED AT THE END OF BLACK BOX. DURING REWIND PUMP GIVES A CALL SERVICE 078-0008 ALARM. UNABLE TO PERFORM STEPS 17-21, 31 AND 35 DUE TO ALARM. UNRELATED, THERE WAS CORROSION IN BATTERY COMPARTMENT. BATTERY COMPARTMENT IS CRACKED AND LEAKS AT THE BATTERY COMPARTMENT. PUMP OPENED; MOISTURE DAMAGE FOUND ON PCB INCLUDING MOTOR FLEX CONNECTOR. CALL SERVICE ALARM DUE TO MOISTURE DAMAGE. ADDITIONALLY, THE DISPLAY WAS DIM AND DISCOLORED. 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

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 550MG/DL, WITH AN ALLEGED CALL SERVICE ALARM ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED PUMP THERAPY, AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS REVEALED THE CALL SERVICE 078 ALARM OCCURRED DURING EACH REWIND STEP AND WAS UNABLE TO BE CLEARED DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A CALL SERVICE ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246966 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R