BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3972661 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22038
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/15/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND OCCURRENCES OF POWER ON RESETS. BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS AREA AND MOISTURE WAS EVIDENT INSIDE THE COMPARTMENT. THE THREADS ON THE BATTERY CAP WERE STRIPPED AND IT WAS UNABLE TO SECURE PROPERLY ONTO THE PUMP. THE PUMP FAILED TO POWER ON USING THE RETURNED BATTERY CAP. THE REPORTED POWER ISSUE WAS VERIFIED IN THE BLACK BOX AND DUPLICATED IN THE INVESTIGATION. USING A TEST BATTERY CAP, THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. NO TACTILE ISSUES WERE OBSERVED WITH THE BUTTONS. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISES WERE EXECUTED WITHOUT INCIDENCES. A LEAK TEST SHOWED A LEAK ON BATTERY COMPARTMENT. THE PUMP CASING WAS OPENED AND NO ADDITIONAL EVIDENCE OF MOISTURE INTRUSION WAS FOUND INSIDE THE PUMP INTERIOR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR 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 AND THE ISSUE WAS RESOLVED WITH A NEW BATTERY. 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
    450333 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR