BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2875066 · Received December 17, 2012

    Report

    Report Number
    2531779-2012-14620
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 24, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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) 2012, THE PATIENT LEFT A MESSAGE WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (CTS) STATING THAT HE FELT THE PUMP WAS DELIVERING WHEN IT SHOULDN'T HAVE BEEN AND HE EXPERIENCED BLOOD GLUCOSE (BG) AROUND 30 MG/DL WITH SEIZURES ON (B)(6) 2012. THE PATIENT STATED HE HAD BEEN EXPERIENCING UNEXPLAINED LOW BG FOR THE "PAST COUPLE OF DAYS." THE PATIENT REPORTED THAT HE HAD BEEN SETTING TEMPORARY BASAL PROGRAMS TO "OFF" FOR AN HOUR AT A TIME, BUT HE FELT THE PUMP WAS DELIVERING DURING THESE TIMES, LEADING TO THE LOW BGS. CTS MADE SEVERAL ATTEMPT TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION AND COMPLETE TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SEVERE HYPOGLYCEMIA ALLEGEDLY RELATED TO THE PUMP DELIVERING EXCESS INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening