BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4101536 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26805
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2014 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION THE REPORTED INTERMITTENT POWER ISSUE WAS DUPLICATED. REVIEW OF BLACK BOX DATA FOUND SEVERAL POWER ON RESET EVENTS. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED AT THE TOP AND BELOW THE GRIP PAD. MOISTURE INTRUSION WAS EVIDENT INSIDE THE COMPARTMENT. THE RETURNED BATTERY CAP WAS UNABLE TO SECURE PROPERLY ONTO THE PUMP AND MAINTAIN ELECTRICAL CONNECTIONS. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUE WAS OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. A 24-HOUR PUMP EXERCISE WAS NOT COMPLETED DUE TO THE INTERMITTENT POWER ISSUE. A LEAK TEST SHOWED LEAKS WHERE THE CRACKS WERE LOCATED. PUMP CASING WAS OPENED AND ADDITIONAL EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE POWER ISSUE, IT WAS OBSERVED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    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. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE AND THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY CAP AND THE CAP WAS ABLE TO SECURE PROPERLY ON TO THE PUMP. THE REPORTER NOTED THAT THERE WAS NO MOISTURE/CORROSION IN THE PUMP. 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
    583607 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR