BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092746 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26358
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/29/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED. A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED AN UNEXPLAINED PUMP REBOOT. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED WITH EVIDENCE OF MOISTURE CONTAMINATION INSIDE. THE BATTERY CAP WAS FOUND TO BE DAMAGED, AND WAS UNABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, AND WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE LEAK TEST FAILED DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WERE FOUND INSIDE THE PUMP.

    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 (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE YELLOW O-RING AT THE BATTERY CAP WAS VISIBLE AT THE TIME OF POWER INTERRUPTION. IT WAS REPORTED THAT THE BATTERY CAP WOULD NOT ATTACH ON TO THE PUMP, AND THAT IT HAD NOT BE REPLACED IN OVER THIRTEEN MONTHS. IT WAS ALSO REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED WITH EVIDENCE OF MOISTURE INSIDE. 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
    571210 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR