BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3933377 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19989
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/28/2014-PRODUCT ANALYSIS:THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/15/2014 WITH THE FOLLOWING FINDINGS:A BATTERY COMPARTMENT CRACK WAS OBSERVED DURING EVALUATION. THE BATTERY CAP THREADS WERE DAMAGED AND UNABLE TO SECURE PROPERLY TO THE PUMP; A POWER ISSUE WAS OBSERVED DURING TESTING. A TEST BATTERY CAP WAS ABLE TO SECURE PROPERLY WITHOUT POWER ISSUE. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE PEELING. EVALUATION REVEALED THAT THE UP KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE UP AND CONTRAST KEY CONTACTS. INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BATTERY COMPARTMENT DAMAGE 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
    409191 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR