BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3060009 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04280
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTER ATTRIBUTED THE EVENT TO EXPOSING THE INSULIN TO TEMPERATURES OUTSIDE OF RECOMMENDATIONS. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/07/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6) 2014. SCRIPTS STATES EVENT OCCURRED ¿(B)(6) 2012.¿ DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. THE CURRENT PUMP HISTORY SHOWS NO ERRORS OR ALARMS ASSOCIATED WITH THE COMPLAINT. TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST. THE BATTERY CAP WAS NOT RETURNED. A NEW TEST CAP WAS ABLE TO TIGHTEN TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED BLOOD GLUCOSE OF 30 MMOL/L RELATED TO ELEVATED TEMPERATURES. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE WOULD ELEVATE WHEN THE TEMPERATURE EXCEEDED THE RECOMMENDED LEVELS. THE REPORTER WANTED TO KNOW IF THERE WAS ANYTHING THAT COULD BE DONE TO PROTECT THE INSULIN FROM EXPOSURE TO HIGH TEMPERATURES. THE REPORTER CONFIRMED THAT THE PUMP ITSELF WAS NOT HOT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO EXPOSURE OF THE INSULIN IN THE PUMP TO TEMPERATURES OUTSIDE OF RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162612 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR