BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3872247 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16832
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/10/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS SEVERAL UNEXPLAINED POWER ON RESET (POR) EVENTS ON (B)(6) 2014. THE PUMP WAS RETURNED WITH A PARTIALLY CHARGED ¿DURACELL-PROCELL ¿ LITHIUM BATTERY. THE TEST BATTERY WAS USED FOR INVESTIGATION. THE RETURNED BATTERY CAP AND CARTRIDGE CAP ARE UNDAMAGED AND THEY WERE USED DURING INVESTIGATION, THE BATTERY COMPARTMENT IS CRACKED AT THE CASE SEAL UP TO THE BUMPER GRIP. THE BATTERY CAP IS ABLE TO FIT SECURELY TO MAINTAIN ELECTRICAL CONNECTION. THE CAP CONTACTS MEASUREMENTS ARE WITHIN SPECIFICATIONS. THE DISPLAY CONTRAST IS DIM AND REDDISH. THE KEYPAD RUBBER IS TORN AROUND ¿UP¿ BUTTON. ALL OF THE BUTTONS RESPOND PROPERLY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. NO POWER INTERRUPTION OCCURRED DURING THE INVESTIGATION, THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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
    349783 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR