BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2920777 · Received January 17, 2013

    Report

    Report Number
    2531779-2013-00822
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. NO BATTERY CAP RETURNED. ALL TESTING PERFORMED WITH A TEST BATTERY CAP. PUMP POWERS WITH A TEST BATTERY CAP TO A DIM DISCOLORED DISPLAY. BATTERY CAP UNABLE TO FULLY TIGHTEN. NO POWER LOSS WAS OBSERVED. PUMP WAS EXERCISED WITH A TEST CAP FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. CURRENT DRAWS WITHIN SPECIFICATIONS. REMOVED PUMP CASE. NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE PUMP 6. BLACK BOX DATES FROM (B)(6) 2014. COMPLAINT WAS LOGGED ON 12/22/2012. NO UNEXPLAINABLE POWER ON RESET EVENTS OBSERVED IN CURRENT BLACK BOX.

    Description of Event or Problem · 1

    ON (B)(4) 2012 THE REPORTER CONTACTED ANIMAS AND ALLEGED HIS PUMP IS RANDOMLY SHUTTING DOWN ON HIM. NO OTHER INFORMATION IS PROVIDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP IS INTERMITTENTLY LOSING POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25954 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR