BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113624 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06447
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED DATES FROM (B)(6) 2013 WITH NO EVIDENCE OF A REBOOT. DURING INVESTIGATION OF THE PUMP, NO DAMAGE OR INTERNAL MOISTURE WAS FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO TIGHTEN ON TO THE PUMP. THE PUMP¿S DISPLAY SCREEN WAS BLANK WHEN ATTEMPTING TO POWER ON THE PUMP. THE POWER ISSUE COULD NOT BE FURTHER TESTED DUE TO THE BLANK DISPLAY. THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. A TEST SCREEN WAS INSTALLED AND DISPLAYED PROPERLY. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS REPORTED THAT THE PUMP HAD NO POWER AND THE DISPLAY SCREEN APPEARED TO BE SHATTERED FROM THE INSIDE WHEN THE PUMP WAS REMOVED FROM A BAG HOLDING SUPPLIES DURING A SPORTS ACTIVITY. 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
    215575 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR