BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2170520 · Received July 21, 2011

    Report

    Report Number
    2531779-2011-05086
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: THE PUMP WAS LOADED WITH A CARTRIDGE FILLED TO 100 UNITS; THE PISTON ACCURATELY STOPS AT 100 UNITS DURING THE LOAD CARTRIDGE STEP. THE FORCE SENSOR CALIBRATION READING WAS FOUND TO BE WITHIN ACCEPTABLE RANGE. THE PUMP WAS OPENED AND THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT OVER THE PAST TWO WEEKS THE PUMP HAS BEEN DISPENSING INSULIN DURING THE LOAD STEP OF A ROUTINE CARTRIDGE CHANGES. SHE STATED THAT SHE DOES NOT RECEIVE A "NO CARTRIDGE DETECTED" WARNING PRIOR TO INSULIN BEING DISPENSED.

    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 53 YR