BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2905595 · Received January 9, 2013

    Report

    Report Number
    2531779-2013-00457
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    ON (B)(6) 2012, THE PATIENT'S WIFE/REPORTER CONTACTED ANIMAS TO REPORT THAT THE PATIENT HAD UNEXPLAINED ELEVATED BLOOD GLUCOSE READING OF 500 MG/DL WHILE ON INSULIN PUMP THERAPY. AT THE TIME OF CONCERN, THE PATIENT HAD MILD NAUSEA AND INCREASED URINATION AND THIRST. THE PATIENT REPORTEDLY TOOK INSULIN SHOTS TO BRING DOWN HIS BLOOD GLUCOSE READING TO 102 MG/DL BUT WITHIN 4 HOURS HIS BLOOD GLUCOSE WAS ELEVATED TO 500 MG/DL AGAIN. THE PATIENT WAS NOT AVAILABLE TO TROUBLESHOOT THE SUBJECT PUMP. ANIMAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT VIA PHONE. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALLBACK. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT HAD ELEVATED BLOOD GLUCOSE READING OVER 500 MG/DL WHILE ON INSULIN PUMP THERAPY. THE PUMP CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12273 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening