BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3090594 · Received May 2, 2013

    Report

    Report Number
    2531779-2013-05822
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    THE REPORTER (PATIENT'S MOTHER) CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) OF 27 MG/DL WITH SHAKING AND SWEATING TWO NIGHTS PRIOR. THE PATIENT'S REPORTED LOW BG WAS SUCCESSFULLY TREATED WITH JUICE AND FOOD INTAKE WITH THE BG RESPONDING TO WITHIN NORMAL RANGE 30-45 MINUTES AFTER EATING. THE REPORTER STATED THAT PATIENT IS NEW TO INSULIN PUMP THERAPY (IPT) AND THE PATIENT'S BG HAS BEEN ERRATIC SINCE BEGINNING IPT IN (B)(6) 2013. THE PATIENT HAS NOT BEEN SEEN BY THE HEALTHCARE PROVIDER SINCE BEGINNING IPT. ANIMAS CUSTOMER TECHNICAL SUPPORT WAS UNABLE TO PERFORM TROUBLESHOOTING ON THE PUMP BECAUSE IT WAS NOT AVAILABLE TO THE REPORTER AT THE TIME OF THE CALL TO ANIMAS. ACTS MADE SEVERAL ATTEMPTS TO FOLLOW UP WITH THE REPORT TO PERFORM TROUBLESHOOTING; HOWEVER, THE REPORTER DID NOT REPLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCE HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITHOUT A KNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193074 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Life Threatening| R