BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4210460 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30770
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 04/22/2015. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/11/2015 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 ALLEGED BATTERY LIFE ISSUE WAS NOT DUPLICATED. REVIEW OF BLACK BOX DATA FOUND THAT THE DATA FROM THE TIME OF THE COMPLAINT WAS OVERWRITTEN DUE TO CONTINUED CUSTOMER USE. REVIEW OF THE AVAILABLE DATA DID NOT FIND EVIDENCE OF SHORT BATTERY LIFE. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. PUMP CASING WAS OPENED AND THERE WAS NO EVIDENCE OF MOISTURE INTRUSION OR LOOSE COMPONENTS INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY LIFE IS LESS THAN EXPECTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. ATTEMPT BY THE CUSTOMER SUPPORT TO FOLLOW-UP ON THE MATTER WAS 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
    691844 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR