BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6796427 · Received August 15, 2017

    Report

    Report Number
    2531779-2017-18294
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 24, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100068
    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 DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2017 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. THE TOTAL DAILY INSULIN DELIVERY RECORDS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE BASAL HISTORY FOR (B)(6) 2017 APPEARS TO BE INACCURATE DUE UNEXPLAINED LOSS OF PRIME AT 07:09; DELIVERIES RESUMED AT 07:18. UNEXPLAINED LOSS OF PRIME AT 8:21; DELIVERIES RESUMED AT 08:30. A REWIND, LOAD, PRIME AT 08:52; DELIVERIES RESUMED AT 09:15. UNEXPLAINED LOSS OF PRIME AT 09:48; DELIVERIES RESUMED AT 09:58. A 0.00U/HR BASAL RATE WAS SET FROM 10:13 TO 10:19. AN UNEXPLAINED LOSS OF PRIME AT 11:28; DELIVERIES NEVER RESUMED. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. ALL DELIVERIES PERFORMED DURING INVESTIGATION WERE RECORDED ACCURATELY IN THE PUMP¿S HISTORY. THE DOWN KEYPAD BUTTON WAS FOUND TO BE UNDER-RESPONSIVE. THE BUTTON CONTACT WAS FOUND TO BE CRACKED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE THAT DAY WAS BETWEEN 250-499 MG/DL WITH NAUSEA AND SYMPTOMS OF DEHYDRATION. THE REPORTER NOTED THE PATIENT DID RECEIVED UNSPECIFIED TREATMENT FROM A HEALTHCARE PROVIDER, THEY DISCONTINUED PUMP THERAPY, AND THE PUMP¿S DELIVERY SETTINGS WERE NOT RECENTLY CHANGED BY A HEALTHCARE PROVIDER. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE PUMP¿S BASAL HISTORY DID NOT MATCH THE PROGRAMMED BASAL RATES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HEALTH EVENT WAS ATTRIBUTED TO AN ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573861 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100068

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening