BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822851 · Received May 21, 2014

    Report

    Report Number
    2531779-2014-14333
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/07/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE REPORTED POWER ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE EVALUATION. REVIEW OF BLACK BOX DATA FOUND THAT THE CURRENT DATE RANGE DID NOT COVER THE COMPLAINT DATE DUE TO CONTINUED CUSTOMER USE. NO EVIDENCE OF SHORT BATTERY LIFE WAS FOUND IN THE AVAILABLE DATE RANGE IN THE BLACK BOX. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. REMOVAL OF PUMP CASING DID NOT FIND EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS INSIDE 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 POWER (BATTERY LIFE) ISSUE. THE REPORTER WAS UNABLE TO COMPLETE THE TROUBLESHOOTING. SEVERAL ATTEMPTS BY THE CUSTOMER SUPPORT TO FOLLOW-UP ON THE MATTER WITH THE REPORTER WERE UNSUCCESSFUL. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303899 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR