BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230568 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11056
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 09/26/2013-DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2013 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP SHOWED THAT THERE WERE SOME COSMETIC DEFECTS. THE SYMBOLS ON THE KEYPAD WERE WORN WITH NO SIGN OF PHYSICAL DAMAGES. THE ¿UP¿, ¿DOWN¿ AND CONTRAST BUTTONS WERE RESPONDING INTERMITTENTLY WHILE THE ¿OK¿ BUTTON RESPONDED TO PRESSES. REMOVAL OF THE RUBBER KEYPAD REVEALED THAT THERE WAS CONTAMINATION UNDER THE BUTTONS THAT WERE RESPONDING INTERMITTENTLY. THE COVER TO THE BOLUS BUTTON WAS FOUND TO BE DETACHED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING BUTTON TACTILE CHANGES. THE "UP", "DOWN" AND "OK" BUTTONS PRODUCE A DELAYED RESPONSE. 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
    329895 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR