BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3010435 · Received March 19, 2013

    Report

    Report Number
    2531779-2013-02815
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. DEVICE EVALUATION: THE BLACK BOX AND DOWNLOAD HISTORY WERE NOT AVAILABLE FOR REVIEW BECAUSE THE PUMP WOULD NOT POWER ON; THERE WAS NO AUDITORY, VIBRATORY OR DISPLAY SCREEN FUNCTIONALITY. ON EXAMINATION, THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT. THERE WAS NO VISIBLE DAMAGE TO THE PUMP CASE, BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP FIT SECURELY ON THE PUMP. TESTING OF THE PUMP WAS NOT ABLE TO BE PERFORMED DUE TO THE PUMP NOT POWERING ON. THE PUMP COVER WAS REMOVED FOR INVESTIGATION AND REVEALED A SINGLE COMPONENT FAILURE DEFECT OF THE POWER CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD RECENTLY LOST POWER WITH NO WARNINGS OR ALARMS. 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
    114083 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR