BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3472548 · Received November 15, 2013

    Report

    Report Number
    2531779-2013-21037
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Report Date
    November 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 01/27/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/14/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED THE FOLLOW ACTIVITY ON 11/04/2013: 69 UNITS REMAIN AT 8:52 AM, A 69 UNIT PRIME OCCURS, A REPLACE CARTRIDGE ALARM OCCURS AT 9:04AM. THE REMAINING INSULIN IS NOT ZERO PRIOR TO ALL OTHER CARTRIDGE CHANGES. THERE ARE NO OTHER REPLACE CARTRIDGE ALARMS ASSOCIATED WITH CARTRIDGE CHANGES. DURING TESTING, THE PUMP WAS PRIMED UNTIL 0 UNITS REMAINED IN THE CARTRIDGE AT WHICH POINT AN EMPTY CARTRIDGE ALARM WAS GIVEN. THE CARTRIDGE WAS REMOVED AND 0 UNITS WERE VISUALLY CONFIRMED REMAINING. UNRELATED TO THE COMPLAINT, THE PUMP¿S HISTORY SHOWED A TIME AND DATE RESET TO FACTORY DEFAULT. THE PUMP WAS OPENED AND THE INTERNAL CLOCK BATTERY WAS FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (REMAINING INSULIN READING) ISSUE. THE REPORTER STATED THAT THE PUMP READS EMPTY CARTRIDGE BUT WHEN THE CARTRIDGE IS REMOVED THERE IS STILL INSULIN IN THE CARTRIDGE. 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
    594725 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR