BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870770 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14487
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    (B)(4): A REVIEW OF THE PUMP HISTORY INDICATED SHOWED NO SIGNS OF "REPLACE BATTERY" ALARMS. DURING TESTING A REPLACE BATTERY ALARM WAS REPRODUCED AND THE ALARM WAS ACCURATELY RECORDED IN THE PUMP HISTORY. A NORMAL BOLUS AND AN AUDIO BOLUS WERE PERFORMED AND CONFIRMED THAT THE BOLUSES WERE RECORDING APPROPRIATELY IN THE PUMP HISTORY. THE KEYPAD WAS TESTED AND CONFIRMED THAT THE BUTTONS WERE RESPONDING APPROPRIATELY WITH NO HYPERSENSITIVE BUTTONS FOUND. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CLAIMED THE ANIMAS INSULIN PUMP DOES NOT RECORD A BATTERY ALARM WARNING. ACCORDING TO THE REPORTER, THE PUMP HAD A REPLACE BATTERY MESSAGE AFTER THE PATIENT ATTEMPTED TO TAKE BOLUS INSULIN VIA THE PUMP. THE BOLUS INSULIN WAS NOT DELIVERED UNTIL THE BATTERY WAS REPLACED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AS THERE IS NO RECORD IN THE HISTORY SHOWING ANY BATTERY ALARM. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE UNRECORDED BATTERY ALARM ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR