BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4223252 · Received November 4, 2014

    Report

    Report Number
    2531779-2014-31394
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA AND ALARM HISTORY REVEALED MULTIPLE UNACKNOWLEDGED ALARMS, AND NO EAW 128-FXXX ALARMS. THERE WAS EVIDENCE OF A PARTIALLY DISCHARGED BATTERY INSTALLED. THERE WAS NO VISIBLE DAMAGE TO THE BATTERY COMPARTMENT. THE PUMP POWERS ON NORMALLY WITH THE RETURNED BATTERY CAP, AND THE CAP FULLY SECURED ONTO THE PUMP. THE CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (128-FXXX) ISSUE. 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
    706146 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR