BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895758 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18344
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 11/16/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. THE ¿UP¿, ¿DOWN¿ AND ¿OK¿ BUTTONS RESPONDED INTERMITTENTLY. REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER ALL THE BUTTON CONTACTS. THE REPORTED BUTTON TACTILE ISSUE WAS DUPLICATED DURING THE INVESTIGATION. UNRELATED TO THE BUTTON ISSUE, THE DISPLAY WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE ¿UP¿, ¿DOWN¿ AND ¿OK¿ BUTTONS WERE UNDER RESPONSIVE. IT WAS REPORTED THAT THE KEYPAD COVER WAS UNDAMAGED AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THE REPORTER DID NOT NOTE ANY DELIVERY ISSUE. 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
    372159 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR