BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2974726 · Received February 22, 2013

    Report

    Report Number
    2531779-2013-02060
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT IN (B)(6) 2012 HER BLOOD GLUCOSE (BG) WAS HIGH IN THE 600-700 MG/DL RANGE FOR TWO TO THREE DAYS. THE PATIENT TOOK CORRECTIONS AND THOUGHT HER BG WOULD DOWN. THE PATIENT STATED SHE STARTED TO VOMIT AND WAS TAKEN TO THE EMERGENCY ROOM. SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND WAS HOSPITALIZED FOR 10 DAYS. THE PATIENT REPORTED SHE WAS ON AN ALTERNATE METHOD SINCE THEN. THE PATIENT ALSO HAD A URINARY TRACT INFECTION AND THE START OF A KIDNEY INFECTION. WHILE SHE WAS IN THE HOSPITAL SHE WAS OFF THE PUMP FOR FIVE DAYS. SHE WAS THEN PUT BACK ON PUMP WITH ALL NEW SUPPLIES AND NEW VIAL OF INSULIN THE PATIENT REPORTED HER BG WENT FROM 400 MG/DL TO 700 MG/DL. PATIENT REPORTED THAT HER HEALTHCARE PROFESSIONAL (HCP) WANTED HER TO GET BACK ON THE PUMP AND ADVISED HER TO CALL TO GET A NEW PUMP. TROUBLESHOOTING INDICATED THAT THERE WAS NO PUMP MALFUNCTION. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE BECAUSE THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S HYPERGLYCEMIC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78601 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L