BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3480430 · Received November 21, 2013

    Report

    Report Number
    2531779-2013-21568
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 03/11/20014. 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/24/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE PUMP HISTORY REVEALED THE LAST BOLUS AND BASAL DELIVERIES WERE RECORDED NOVEMBER 13, 2013. THE BLACK BOX DATA REVEALED A 13 HOUR, 44 MINUTE INTERRUPTION OF POWER BETWEEN (B)(4) 2013 18:50 AND (B)(4), 2013 08:34. NO INSULIN DELIVERY OCCURRED DURING THIS TIME. THERE WAS NO RECORD OF ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE TOTAL DAILY DOSE AMOUNTS ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATE. EXAMINATION DID NOT REVEAL ANY DAMAGE TO EITHER THE BATTERY COMPARTMENT OR THE BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY LOSS OR INTERRUPTION IN POWER AND NO ALARMS. INVESTIGATION FOUND THE PUMP TO BE DELIVERING ACCURATELY AND OPERATING WITHIN REQUIRED RANGE. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UNKNOWN MEASUREMENT WHILE ON INSULIN PUMP THERAPY. THIS REPORTED EVENT DOES NOT MEET ANIMAS¿ CRITERIA OF A REPORTABLE ADVERSE EVENT. THE DISTRIBUTOR REPORTED THAT TROUBLESHOOTING OF THE PUMP DID NOT REVEAL ANY MALFUNCTION. THE PATIENT REPORTEDLY DISCONTINUED USE OF THE SUBJECT INSULIN PUMP AND BEGAN TREATMENT USING A DIFFERENT PUMP WITH THE ELEVATED BG RETURNING TO WITHIN NORMAL RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE OF INACCURATE DELIVERY REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606493 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1