BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3953548 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21165
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/13/2014 WITH THE FOLLOWING FINDINGS: NO DAMAGE FOUND TO THE DISPLAY LENS. THE BATTERY COMPARTMENT IS CRACKED NEAR THE CASE SEAL. RETURNED BATTERY CAP FULLY ATTACHES TO THE PUMP AND WAS USED TO COMPLETE TESTING. THE PUMP POWERS ON WITH VIBRATORY AND AUDIBLE SOUNDS. A REWIND, LOAD AND PRIME SEQUENCE WERE SUCCESSFULLY PERFORMED. THE BLACK BOX SHOWS NO UNUSUAL FLUCTUATION OF THE VOLTAGE. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND IDLE, SLEEP, REWIND AND LOAD CURRENTS ALL ARE WITHIN SPECIFICATION. NO OVERHEATING WAS DUPLICATED DURING TESTING. REMOVED THE PUMP COVER AND THERE WAS NO EVIDENCE OF LOOSE COMPONENTS OR MOISTURE CONTAMINATION IDENTIFIED INSIDE PUMP. THE AUDIO BOLUS BUTTON COVER IS MISSING FROM THE PUMP.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - PHYSICAL DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT AND DISPLAY LENS WERE DAMAGED. 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
    429885 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR