BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971146 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21964
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/16/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED UNEXPLAINED PUMP REBOOTS. THE BATTERY COMPARTMENT WAS CRACKED. THE RETURNED BATTERY CAP HAD STRIPPED THREADS, AND WAS UNABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP COULD NOT BE EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP, DUE TO DUPLICATED PUMP REBOOTS. A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION. THE TEST CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE TEST BATTERY CAP WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE PUMP WAS OPENED AND THERE WAS NO EVIDENCE OF MOISTURE OR DAMAGE OBSERVED INSIDE THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE YELLOW ORING AT THE BATTERY CAP WAS VISIBLE DURING POWER INTERRUPTION AND THAT THE BATTERY COMPARTMENT WAS CRACKED. 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
    448531 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR