BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3112172 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06379
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT IN (B)(6) 2012 THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) AND WAS IN THE HOSPITAL. THE SPECIFIC DATE OF THE INCIDENT WAS NOT PROVIDED. SPECIFIC BG VALUES AND DETAILS OF THE INCIDENT COULD NOT BE PROVIDED. THE PATIENT HAD REPORTEDLY BEEN OFF THE PUMP FOR SEVERAL MONTHS PRIOR TO THE REPORTED INCIDENT BECAUSE THE BATTERY CAP WAS BROKEN. THE PATIENT DID NOT CALL INTO ANIMAS ABOUT THE BATTERY CAP ISSUE. THE REPORTER DENIED POWER ISSUES. THE PUMP WAS UNAVAILABLE FOR REVIEW, AS IT WAS REPORTEDLY STOLEN IN (B)(6) 2013. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AFTER CESSATION OF INSULIN PUMP THERAPY DUE TO AN ISSUE WITH THE BATTERY CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212402 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R