BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2240015 · Received September 8, 2011

    Report

    Report Number
    2531779-2011-06656
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DATA FROM THE TIME OF THE EVENT WAS AVAILABLE IN THE PUMP BLACK BOX HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE WAS RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    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 PATIENT CONTACTED ANIMAS ON (B)(6) 2011 TO REPORT SHE OBTAINED A CALL SERVICE ALARM 064-0001 WHILE PRIMING THE SUBJECT PUMP. AT THE TIME OF THE CALL, THE PATIENT INFORMED CUSTOMER SUPPORT THAT SHE WAS HOSPITALIZED WITH A DIAGNOSIS OF DKA. THE PATIENT REPORTED THAT SHE BEGAN TO FEEL "ILL" ON (B)(6) 2011 AND THE "ILLNESS" PROGRESSED OVER THE WEEK. ON (B)(6) 2011, THE PATIENT CLAIMED SHE STARTED VOMITING, COULD NOT KEEP FLUIDS DOWN, FELT DIZZY AND DEVELOPED SHORTNESS OF BREATH. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE CONTACTED EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT STATED SHE WAS TAKEN TO THE EMERGENCY ROOM WHERE SHE WAS PLACED ON AN INSULIN DRIP/IV FLUIDS AND TRANSFERRED TO ICU. AT THE TIME OF THE CALL, THE PATIENT STATED SHE WAS STILL HOSPITALIZED AND CONFIRMED SHE WAS NOT CONNECTED TO THE PUMP WHEN SHE OBTAINED THE CALL SERVICE ALARM WHEN PRIMING IT. THE PATIENT WAS UNWILLING TO DO ANY TROUBLESHOOTING AT THE TIME OF THE CALL. CUSTOMER SUPPORT ATTEMPTED TO REACH THE PATIENT TO CONTINUE TROUBLESHOOTING; HOWEVER, WERE UNSUCCESSFUL IN THEIR FOLLOW-UP ATTEMPTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED FOR A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R