BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241949 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11662
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/10/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/20/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH TORN KEYPAD ABOVE THE ¿UP¿ KEY. ALL KEYPAD BUTTONS WERE COMPLETELY UNRESPONSIVE. WHEN THE KEYPAD WAS REMOVED TO INVESTIGATE, EVIDENCE OF KEYPAD CONTAMINATION WAS LOCATED, UNDER ALL KEYPAD BUTTONS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING AN UNRESPONSIVE KEYPAD ISSUE. ONE WEEK PRIOR TO THE COMPLAINT, THE "OK" AND "DOWN" BUTTONS BECAME INTERMITTENTLY RESPONSIVE. THE DAY BEFORE THE COMPLAINT, THE ISSUE PROGRESSED AND THE TWO BUTTONS BECAME COMPLETELY UNRESPONSIVE. 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
    341026 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR