BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2161336 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04920
    Event Type
    Injury
    Date Received
    July 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR AN UNRELATED ISSUE AND WAS INVESTIGATED AND DISASSEMBLED ON (B)(4) 2011. PRODUCT ANALYSIS ATTEMPTED TO RECOVER THE DEVICE FOR ADDITIONAL INVESTIGATION HOWEVER THE PUMP WAS UNABLE TO BE INVESTIGATED DUE TO DISASSEMBLY. (B)(4). PRIOR EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) IN THE RANGE OF 600MG/DL WITH SHORTNESS OF BREATH. THE BG WAS TREATED VIA SYRINGE AND THE BG WENT DOWN TO 200MG/DL. THE FAMILY MEMBER REPORTED THAT THE FOLLOWING DAY THE PATIENT'S BG WENT HIGH AND THE EMT WAS CALLED AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. HE WAS REPORTEDLY TREATED WITH INSULIN AND RELEASED. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER TO DISCUSS SITE ROTATION WITH THE PATIENT'S HEALTHCARE PROFESSIONAL. THE FAMILY MEMBER REFUSED TO TROUBLESHOOT THE PUMP. THE PATIENT CONTINUES TO USE THE PUMP WITH NO FURTHER REPORTED INCIDENTS. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    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 40 YR Required Intervention