BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241605 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11609
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PRIME HISTORY HAD RECORDED SEVERAL LARGE PRIME VOLUME WARNINGS. DURING TESTING, AN ATTEMPT TO DO THE REWIND AND LOAD STEPS WERE PERFORMED BUT THE PUMP EMITTED A CARTRIDGE NOT DETECTED ALARM. THE FORCE SENSOR CALIBRATION AND RESISTANCE WERE FOUND TO BE OUT OF SPECIFICATIONS. THE PUMP WAS OPENED AND THE FORCE SENSOR PLATE WAS FOUND TO BE CONTAMINATED. THE PISTON WAS INVESTIGATED AND FOUND TO BE WITHIN SPECIFICATIONS. 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 PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR CALIBRATION AND RESISTANCE WERE NOT WITHIN SPECIFICATIONS. THERE WAS CONTAMINATION FOUND ON THE FORCE SENSOR PLATE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340542 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR