BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3113759 · Received May 15, 2013

    Report

    Report Number
    2531779-2013-06452
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/22/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP HAS AUDIBLE AND VIBRATORY SOUNDS; THE DISPLAY SCREEN REMAINS BLANK AND DOES NOT GO THE VERIFY SCREEN. THE PUMP COVER WAS REMOVED AND THE IT WAS CONFIRMED THE DISPLAY SCREEN IS CRACKED. INSERTED TEST DISPLAY SCREEN. TEST DISPLAY SCREEN POWERS ON THE VERIFY SCREEN WITH NORMAL CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT THE PREVIOUS EVENING, THE PATIENT FELL OFF A CHAIR AND NOW THE PUMP'S DISPLAY SCREEN IS BLANK AND THERE IS A CRACK UNDER THE LENS. THE PATIENT WAS REPORTEDLY STARTED ON AN ALTERNATE FORM OF INSULIN DELIVERY AFTER WHICH THE PATIENT REPORTEDLY EXPERIENCED BLOOD GLUCOSE (BG) OF 430MG/DL WITH NO SYMPTOMS. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED DISPLAY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215624 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR