BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3844447 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15555
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 07/08/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/01/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT ONE LOW BATTERY ALARM AND ONE REPLACE BATTERY ALARM WAS RECORDED. THERE WAS NO EVIDENCE OF EXCESSIVE BATTERY USAGE OR SHORT BATTERY LIFE OBSERVED IN THE BLACK BOX HISTORY. THE BATTERY COMPARTMENT WAS INTACT; NO DAMAGE WAS OBSERVED. THE RETURNED BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. DURING TESTING, THE PUMP POWERED ON TO THE ¿VERIFY¿ SCREEN IN ACCORDANCE WITH NORMAL OPERATION. THE PUMP¿S ELECTRICAL CURRENT DRAWS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. THERE WAS NO EVIDENCE OF INTERMITTENT CONTACT ON THE BATTERY TERMINAL CONTACTS. THE COMPLAINT OF SHORT BATTERY LIFE WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP 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
    321683 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR