BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2243328 · Received September 12, 2011

    Report

    Report Number
    2531779-2011-06715
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 :12/17/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2015 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX DATA WAS OVERWRITTEN DUE TO CONTINUED PATIENT USE OF THE PUMP. THE CURRENT BLACK BOX SHOWED NO EVIDENCE OF THE ALLEGED DATE ISSUE. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND CONFIRMED THAT THE TIME AND DATE WERE KEPT ACCURATELY. THE BATTERY WAS REMOVED FOR 23 HOURS AND THE PUMP WAS FOUND TO MAINTAIN THE TIME AND DATE. THE PUMP WAS OPENED AND NO MOISTURE OR LOOSE COMPONENTS WERE FOUND. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO BE DIM AND DISCOLORED AND THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP WAS OFF BY A DAY. THE FAMILY MEMBER REPORTED THAT AT MIDNIGHT GOING FROM (B)(6) 2011, THE PUMP DID NOT CHANGE THE DATE. THE FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PUMP EMITTED AN EXCEEDS MAX TOTAL DAILY DOSE ALARM. THE FAMILY MEMBER REPORTEDLY CHANGED THE BATTERY AND THE PUMP DID MAINTAIN THE PROGRAMMED TIME AND DATE. THE FAMILY MEMBER REPORTED THAT THE PUMP HAS NOT LOST ANY TIME OR DATE SINCE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR