BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233561 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11246
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 8, 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND HISTORY DOWNLOAD WERE UNAVAILABLE DUE TO MOISTURE IN THE PUMP. THERE WAS VISIBLE MOISTURE IN DISPLAY. THE PUMP WOULD NOT POWER ON. TESTING COULD NOT BE COMPLETED FOR THE KEYPAD COMPLAINT DUE TO THE PUMP NOT POWERING ON. CONTAMINATION WAS OBSERVED UNDER THE CONTRAST AND UP ARROW KEY CONTACTS. LEAK TESTING FAILED DUE TO A CRACK IN CASE. MOISTURE AND CORROSION WERE OBSERVED ON ALL INTERNAL PUMP SURFACES. (B)(4).

    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. AFTER EXPOSURE TO MOISTURE, ALL OF THE KEYPAD BUTTONS ARE 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
    335618 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR