BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251734 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12001
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED SEVERAL LOSS OF PRIME WARNINGS DUE TO ZERO FORCE DURING THE REPORTED EVENT DATE. DURING TESTING, THE PUMP POWERED ON WITH A BATTERY ALARM WHICH COULD NOT BE CLEARED. THE LOAD STEP MALFUNCTION COULD NOT BE TESTED DUE TO THIS. THE PUMP WAS OPENED AND THERE WAS NO DAMAGE FOUND TO THE INTERNAL CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT ALL THE INSULIN WAS DISPENSED DURING THE LOAD STEP. 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
    353553 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR