BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2240329 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06666
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE LOAD CARTRIDGE STEP WAS UNABLE TO DETECT THE CARTRIDGE. DURING EVALUATION, CONTAMINATION WAS OBSERVED IN THE FORCE SENSOR ASSEMBLY AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    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

    IT WAS REPORTED THE PATIENT HAD DIFFICULTY LOADING THE INSULIN CARTRIDGE; AFTER THE CARTRIDGE WAS LOADED WITH 100 UNITS, THE PUMP INSULIN GAUGE STATED THERE WERE 205 UNITS REMAINING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. THE COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED INCORRECT INSULIN GAUGE ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR