BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2193540 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05646
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED AS EXPECTED. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD. NO DEFECT WAS FOUND ON INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, ALL THE KEYPAD BUTTONS ARE UNRESPONSIVE. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ANIMAS PRODUCT IS BEING RETURNED FOR INVESTIGATION. THE PATIENT WAS ADVISED TO GO ON THE BACKUP AS NEEDED.THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    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 9 YR