BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6045531 · Received October 20, 2016

    Report

    Report Number
    2531779-2016-29282
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    October 4, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. FOLLOW UP #1: THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT. THE PRODUCT WAS UPDATED FROM THE PUMP TO THE BATTERY CAP ALONE. THE CAP COULD NOT BE FULLY TIGHTENED AND THE YELLOW O-RING WAS SHOWING. THE BATTERY CAP. THE 510(K) NUMBER IS K032257. IF THE BATTERY CAP 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) 2016, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE READING OF 400MG/DL WITH EXTREME DROWSINESS, NAUSEA, SYMPTOMS OF DEHYDRATION, AND VOMITING. THE PATIENT REMAINED ON THE PUMP AT THE TIME OF THE CALL AND THERE WAS NO TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. IT WAS ALSO REPORTED THAT THERE WAS A CRACK IN THE BATTERY COMPARTMENT AND THE BATTERY CAP COULD NOT BE TIGHTENED. AT THE SAME TIME THERE WAS AN ALLEGATION OF AN INTERMITTENT POWER ISSUE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING: THERE IS THE POSSIBILITY THAT THE DAMAGE TO THE PUMP CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695257 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR