BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2895461 · Received January 3, 2013

    Report

    Report Number
    2531779-2013-00160
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OF BETWEEN 400-600 MG/DL WITH NAUSEA SINCE THIS MORNING. THE REPORTER STATED THE PATIENT RECEIVED A CORRECTION BOLUS OF INSULIN VIA SYRINGE. THE REPORTER STATED THAT WHEN THE PATIENT ATTEMPTS TO PRIME TO PUMP, THE PUMP MAKES A "CLICKING" NOISE AND THE PATIENT IS UNABLE TO PRIME THE PUMP. THE REPORTER WAS UNABLE TO TROUBLESHOOT THE PUMP AT THE TIME OF THE CALL TO ANIMAS AND STATED HE WOULD CALL BACK LATER WHEN HE GOT HOME TO TROUBLESHOOT THE PUMP. THE REPORTER DID NOT CALL BACK AS STATED. ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, BUT THE CALLS AND LETTERS WENT UNANSWERED BY THE REPORTER. NO FURTHER INFORMATION WAS AVAILABLE. THE REPORTED ISSUE OF THE PUMP NOT PRIMING IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE, THE DETECTABLE FLAW MAY PREVENT THE USER FORM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED AND TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG WHILE ON INSULIN PUMP THERAPY WITH A PUMP THAT THE PATIENT WAS NOT ABLE TO PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R