BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4855096 · Received June 18, 2015

    Report

    Report Number
    2531779-2015-20400
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/06/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM THE DATE OF THE EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE DEVICE. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. THE CURRENT BLACK BOX SHOWED NO EVIDENCE OF SHORT BATTERY LIFE AND THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND THE BATTERY COMPARTMENT WAS INTACT. CURRENT ELECTRICAL DRAWS WERE WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INTERNALLY. 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. (B)(4).

    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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP'S BATTERY LIFE DID NOT MEET THE EXPECTATIONS OF THE USER. 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
    397456 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR