BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2133520 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04273
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE PUMP'S ALARM HISTORY. THE FORCE SENSOR WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. EVALUATION REVEALED A STUCK BALL SEAL IN THE DRIVE ASSEMBLY. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE PUMP PUSHED 70 UNITS OF INSULIN OUT OF THE CARTRIDGE DURING THE LOAD STEP WHILE PERFORMING A ROUTINE CARTRIDGE CHANGE.

    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 14 YR