BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120298 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27538
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/12/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT THE PUMP TIME AND DATE HAD RESET AFTER A POWER REBOOT EVENT WITH THE BATTERY REMOVED FOR 5 MINUTES. THE PUMP WAS EXERCISED FOR 24 HOURS FOLLOWED BY REMOVING THE BATTERY. THE PUMP TIME AND DATE RESET AFTER 6 HOURS WITHOUT POWER. THE PUMP CASE WAS REMOVED AND THE INTERNAL CLOCK BATTERY WAS FOUND TO BE LEAKING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE CASE SEAL AND THE BATTERY CAP. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THE RETURNED BATTERY CAP WAS USED TO COMPLETE ALL TESTING. 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 AT THE TIME OF THIS REPORT. 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

    THE REPORTER CONTACTED ANIMAS AGAIN ON (B)(6) 2014 AND PROVIDED SOME ADDITIONAL INFORMATION ABOUT THE COMPLAINT. THE REPORTER STATED THAT THE INITIALLY REPORTED TIME/DATE ISSUE WITH THE PUMP WAS THAT THE PUMP'S CLOCK WAS RESETTING TO THE DEFAULT VALUE WHEN A BATTERY WAS REINSERTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN UNSPECIFIED ISSUE WITH THE TIME AND DATE OF THE PUMP. TROUBLESHOOTING COULD NOT BE COMPLETED DURING THE CALL. THERE WAS NO ALLEGATION THAT THIS ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601646 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR