BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2871021 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14513
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/06/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2012 HAVE BEEN OVERWRITTEN. THE CURRENT PUMP HISTORY WAS REVIEWED AND NO EVIDENCE OF BATTERY LIFE ISSUE WAS OBSERVED. BATTERY VOLTAGES IN THE BLACK BOX ARE WITHIN NORMAL SPECIFICATIONS. THE TOTAL DAILY DOSE ADDS UP CORRECTLY. PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. AN EXTERNAL POWER SUPPLY WAS USED TO TEST THE IDLE, SLEEP, REWIND AND LOAD CURRENTS; ALL WERE FOUND TO BE WITHIN SPECIFICATION. REMOVED THE PUMP COVER; NO INTERMITTENT CONNECTIONS OR MOISTURE DAMAGE WAS OBSERVED. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, INFORMATION FOR THE COMPLAINT IS 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S DAD/REPORTER CONTACTED ANIMAS TO REPORT THAT THE PATIENT'S BLOOD GLUCOSE READING WAS AT 595 MG/DL AFTER THE ANIMAS INSULIN PUMP LOST POWER FOR 90 MINUTES. IN ADDITION, THE PATIENT REPORTEDLY CONSUMED A LARGE MEAL AT SCHOOL AND WAS GIVEN 5 UNITS OF INSULIN ABOUT 30 MINUTES PRIOR TO THE CALL TO ANIMAS. THE PATIENT'S BLOOD GLUCOSE READING DECREASED TO 518 MG/DL WITHIN 30 MINUTES OF THE BOLUS DOSE. THE PATIENT'S FATHER WAS NOTIFIED IMMEDIATELY AFTER TALKING WITH THE PATIENT. THE BATTERIES WERE REPLACED AND THE SUBJECT PUMP IS WORKING AS DESIRED. THE ISSUE WAS RESOLVED WITH TRAINING. THE PATIENT WAS ADVISED TO MONITOR HER BLOOD GLUCOSE READING AND TO CONTACT HER HCP AS NEEDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY. IN ADDITION, USE ERROR RELATED TO THE SUBJECT PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT.

    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 15 YR Life Threatening