BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832829 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13621
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 21, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2012 - DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE PUMP SETTINGS REVEALED THE INSULIN ON BOARD ENABLE FUNCTION WAS SET TO "ON" AND INSULIN ON BOARD DURATION WAS SET FOR FOUR HOURS. A 10 UNIT BOLUS WAS PROGRAMMED WITH THE INSULIN ON BOARD ENABLED AND SET TO "ON" AND THE INSULIN ON BOARD DURATION SET FOR TWO HOURS. AFTER TWO HOURS, THE INSULIN ON BOARD STATUS WAS 0.00 UNITS REMAINING AND THIS WAS ACCURATELY REFLECTED ON THE INSULIN ON BOARD STATUS SCREEN. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT.

    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

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT AN ISSUE WITH THE PUMP'S INSULIN ON BOARD FUNCTION AND ALLEGED THE PUMP WAS NOT CORRECTLY CALCULATING THE NEXT BOLUS DOSE. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF 292 MG/DL, WITH NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. THE ISSUE WAS NOT RESOLVED.

    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 55 YR