BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2963501 · Received February 15, 2013

    Report

    Report Number
    2531779-2013-01833
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PATIENT WAS FOUND PASSED OUT ON THE FLOOR. THE PATIENT WAS GIVEN 4 JUICE BOXES AND THEIR BLOOD GLUCOSE LEVEL WAS AT 66MG/DL. THE PATIENT HAD REPORTEDLY CHANGED THE CARTRIDGE, BUT NOT THE TUBING AND PRIMED THE PUMP. THE PATIENT REPORTEDLY THEN CHANGED THE BATTERY AND PRIMED 2 MORE TIMES. THE PATIENT REPORTEDLY MAY HAVE BEEN ATTACHED TO THE TUBING FOR SOME OF THESE PRIMES. THE PUMP USER GUIDE INSTRUCTS USERS TO DISCONNECT FROM THE INFUSION SET PRIOR TO PRIMING IT. ADDITIONALLY, THE PUMP NOTIFIES THE USER TO DISCONNECT FROM THE INFUSION SET THREE TIMES DURING THE PRIME / REWIND SEQUENCE. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE LEVELS RELATED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68497 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention