BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242437 · Received November 11, 2014

    Report

    Report Number
    2531779-2014-32168
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/14/2015 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. A REVIEW OF THE PUMP¿S BLACK BOX DATA AND ALARM HISTORY REVEALED NO EVIDENCE OF A POWER ISSUE OR SHORT BATTERY LIFE. THERE WAS NO VISIBLE DAMAGE TO THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, AND WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE ELECTRICAL CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS OBSERVED INSIDE THE PUMP. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726970 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR