BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4060441 · Received September 4, 2014

    Report

    Report Number
    2531779-2014-25113
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/22/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED UNEXPLAINED PUMP REBOOTS. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE BATTERY AND CARTRIDGE CAPS WERE NOT RETURNED WITH THE PUMP, AND TEST BATTERY AND CARTRIDGE CAPS WERE USED TO COMPLETE THE INVESTIGATION. THE TEST BATTERY CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP POWERED ON NORMALLY, AND WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR DAMAGE WAS OBSERVED TO THE INTERNAL COMPONENTS OF THE PUMP. 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 (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. IT WAS REPORTED THAT THE YELLOW O-RING AT THE BATTERY CAP WAS VISIBLE AT THE TIME OF POWER INTERRUPTION AND THAT THE BATTERY CAP HAD NEVER BEEN REPLACED. 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
    541884 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR