BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3083432 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05561
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING LOW BLOOD GLUCOSE (BG) OF 72 MG/DL WITH CONFUSION. THE PATIENT TREATED THE LOW BG WITH CONSUMPTION OF JUICE AND A DONUT. THE PATIENT REPORTED HIS BG AT 86 MG/DL AT THE TIME OF THE CALL. THE PATIENT REPORTED THAT HIS HEALTHCARE PROVIDER (HCP) HAS RECENTLY MADE ADJUSTMENTS TO THE PUMP SETTINGS IN AN ATTEMPT TO CORRECT THE PATIENT'S RECENT ISSUES WITH LOW BG. THE PATIENT STATED THAT THE PUMP EMITTED A LOSS OF PRIME WARNING AFTER PLACING A NEW CARTRIDGE IN THE PUMP. THE PATIENT STATED THAT HE RECALLED PUSHING HARD ON THE CARTRIDGE WHEN INSERTING IT INTO THE PUMP. DURING TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT, IT WAS DISCOVERED THAT THE PATIENT HAD FORGOTTEN TO REWIND THE PUMP BEFORE LOADING THE CARTRIDGE AND PUSHED ALL THE INSULIN OUT OF THE CARTRIDGE. THE PATIENT DENIED KNOWLEDGE OF ANY WETNESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED LOW BG WHILE ON INSULIN PUMP THERAPY AS A RESULT OF DISEASE MANAGEMENT ISSUES AND MISUSE WHEN THE PATIENT NEGLECTED TO REWIND THE PUMP BEFORE INSERTING THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185651 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR