BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840790 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13813
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1. (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP WAS PROGRAMMED ON A ONE UNIT PER HOUR BASAL RATE AND EXERCISED FOR 24 HOURS AND NO UNPROGRAMMED BOLUSES WERE DELIVERED OR RECORDED IN THE PUMP HISTORY DURING THIS TIME. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS TESTED AND ALL KEYS ARE RESPONSIVE TO USER INPUT. THE COMPLAINT WAS NOT ABLE TO BE DUPLICATED DURING THE INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP HISTORY LISTED BOLUSES AND TIMES THAT HAD NOT BEEN PROGRAMMED INTO THE PUMP BY THE USER, AND SHE NOTED THESE BOLUSES HAD NOT BEEN DELIVERED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    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 11 YR