BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3151275 · Received June 7, 2013

    Report

    Report Number
    2531779-2013-07870
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/05/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; THERE WAS NO PEELING OR DAMAGE OBSERVED. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES TO ELICIT A RESPONSE; THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE HARD TO PRESS AND REQUIRED INCREASED FORCE TO ELICIT A RESPONSE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253289 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR