BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082733 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05503
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    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. 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.

    Description of Event or Problem · 1

    THE REPORTER (A HEALTHCARE PROVIDER) CONTACTED ANIMAS ON (B)(6) 2013 TO REPORT THAT THE PATIENT HAD BEEN HOSPITALIZED THE PRIOR DAY WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). THE REPORTER STATED THAT THE PATIENT WAS OUT OF THE HOSPITAL. ANIMAS CUSTOMER TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT IN FOLLOW UP OF THE REPORTED HOSPITALIZATION AND DIAGNOSIS OF DKA AND TO TROUBLESHOOT THE PUMP FOR MALFUNCTION, BUT THE PATIENT DID NOT RETURN THE PHONE CALLS OR THE WRITTEN COMMUNICATIONS SENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS HOSPITALIZED WITH DKA; THE CAUSE OF THE DKA AND THE FUNCTIONALITY OF THE PUMP REMAIN UNKNOWN AT THE TIME OF THIS REPORT. IF MORE INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185472 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR