BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2990030 · Received March 5, 2013

    Report

    Report Number
    2531779-2013-02374
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED LOSS OF PRIME. A REWIND, LOAD, AND PRIME SEQUENCE WAS PERFORMED WITH NO LOSS OF PRIMES OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF PRIME OCCURRING. INVESTIGATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THERE WAS EVIDENCE OF CONTAMINATION OBSERVED ON THE FORCE SENSOR PLATE. UNRELATED TO THE FORCE SENSOR ISSUE, EVALUATION REVEALED A DISCOLORED/FADED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. 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 LOSS OF PRIME. INVESTIGATION REVEALED CONTAMINATION ON THE FORCE SENSOR. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94268 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR