BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2895434 · Received January 3, 2013

    Report

    Report Number
    2531779-2013-00157
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    : THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6)2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE BLACK BOX/ALARM HISTORY SHOWS NO EVIDENCE OF ANY CS-088 ALARM. PUMP WAS EXERCISED FOR 24HR DURATION PERIOD; NO CALL SERVICE ALARMS WERE DUPLICATED DURING THIS TIME. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. REMOVED PUMP COVER; NO EVIDENCE OF INTERNAL MOISTURE WAS OBSERVED. NO DAMAGE TO THE PCB WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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. (B)(4).

    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) 2012 REPORTING THAT THE PUMP EMITTED A CS 088 ALARM; THE PATIENT REPORTED NOT RESPONDING TO THE ALARM FOR TWO HOURS RESULTING IN A BLOOD GLUCOSE OF 30.8 MMOL/L. THE PATIENT REPORTED THAT NO ALTERNATE FORM OF INSULIN DELIVERY WAS USED WHILE THE PUMP WAS ALARMING. THE PATIENT WAS ADVISED TO REBOOT THE PUMP TO CLEAR THE ALARM. THE PATIENT CONFIRMED THAT UPON REBOOT THE ALARM WAS CLEARED, THE TIME AND DATE WERE CORRECT, AND ALL OF THE BASAL RATES WERE APPROPRIATE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO FAILURE TO RESPOND TO A PUMP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening