BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3132451 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07166
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE DUPLICATED. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED THE INFORMATION HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP AFTER THE REPORTED EVENT. THE CURRENT BLACK BOX DATA REVEALED NO POWER ISSUES. DURING TESTING, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE BATTERY CAP WAS RETURNED WITH NO VISIBLE DAMAGE. THE BATTERY CAP CONTACT MEASURED WITHIN SPECIFICATIONS AND THE CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND NO EVIDENCE OF MOISTURE OR DAMAGE WAS OBSERVED TO THE POWER CIRCUIT. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP¿S DISPLAY WAS BLANK. IT WAS NOTED THAT THE PUMP HAD VIBRATORY WARNINGS BUT DUE TO DEAFNESS, THE PATIENT WAS UNABLE TO HEAR AUDIO TONES. THE REPORTER DECLINED TROUBLESHOOTING AT THE TIME OF THE COMPLAINT. IT WAS UNCLEAR IF THE BLANK DISPLAY WAS DUE TO A POWER ISSUE OR NOT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235865 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR