BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2950397 · Received February 8, 2013

    Report

    Report Number
    2531779-2013-01637
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. THE REPORTER STATED THAT THE PUMP WAS ALARMING FOR OCCLUSIONS. THE OCCLUSION ALARM ISSUE IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT BECAUSE THE PUMP ALARMED TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PUMP WAS EMITTING RANDOM OCCLUSION ALARMS WHICH RESULTED IN THE PATIENT EXPERIENCING A BLOOD GLUCOSE OF 500 MG/DL. THE REPORTER STATED THAT THE RANDOM OCCLUSIONS STARTED A FEW DAYS EARLIER AND THEY HAD NEVER SEEN THEM BEFORE. THE REPORTER STATED THAT ON ONE OCCASION THE OCCLUSION ALARM OCCURRED DURING THE NIGHT RESULTING IN THE ELEVATED BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WITH THE REPORTER INDICATED THAT THE PUMP COULD PRIME WITHOUT BEING CONNECTED AT THE SITE. THE REPORTER WAS ADVISED ON CHANGING OUT THE SITE AND THE SET TO CLEAR THE ALARMS. THE REPORTER DECLINED STATING THAT THEY THOUGHT THE ISSUE WAS RELATED TO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO OCCLUSION ALARMS ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54327 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening