BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801418 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13013
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/27/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/21/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO EVIDENCE OF POWER REBOOTS WAS RECORDED. THE BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP AND WAS NOT ABLE TO MAINTAIN AN ELECTRICAL CONNECTION. THE BATTERY CAP THREADS WERE FOUND TO BE STRIPPED/DAMAGED. ADDITIONALLY, EVALUATION REVEALED THAT THERE WAS A CRACK ALONG THE BATTERY COMPARTMENT THREADS. POWER LOSSES WERE DUPLICATED DURING INVESTIGATION. A TEST BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION. THE PUMP WAS ABLE TO COMPLETE A 24 HOUR DURATION TEST USING A TEST BATTERY CAP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT THE BATTERY CAP WAS DAMAGED AND 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
    278989 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR