BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4112372 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27251
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 11, 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

    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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/19/2014 WITH THE FOLLOWING FINDINGS: TEST BATTERY CAP AND TEST CARTRIDGE CAP WERE USED TO COMPLETE THE INVESTIGATION, MOISTURE CONDENSATION IS OBSERVED INSIDE THE PUMP ON THE DISPLAY SCREEN. THE PUMP FAILED A LEAK TEST DUE A LEAK RESULTED BY CRACK BETWEEN THE DISPLAY LENS AND THE CASE SEAL. BLACK BOX AND ALARM HISTORY SHOWS SEVERAL ¿CS078-0008¿ ALARMS ON (B)(6) 2014. THE PUMP POWERS ¿ON¿ WITH AUDITORY AND VIBRATION ALERT BUT THE DISPLAY SCREEN REMAINS BLANK UPON START UP. THE PUMP¿S COVER WAS REMOVED, MOISTURE CORROSION WAS FOUND INSIDE THE PUMP ON THE RF CIRCUIT AND THE DISPLAY SCREEN. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) 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
    589767 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR