BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2870988 · Received December 12, 2012

    Report

    Report Number
    2531779-2012-14509
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 01/28/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THE PUMP SUCCESSFULLY POWERED UP WITH NO ISSUES WITH THE APPROPRIATE AUDIBLE AND VIBRATORY SOUNDS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO ALARMS. THE KEYPAD WAS TESTED AND ALL KEYS WERE FOUND TO BE RESPONSIVE TO USER INPUT. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. THE AUDIO BOLUS BUTTON WAS FOUND TO BE INTACT AND RESPONSIVE TO USER INPUT. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. A 1.0 UNIT COMBO BOLUS WAS PERFORMED AND ENTIRE BOLUS WAS SUCCESSFULLY DELIVERED AFTER AN HOUR. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THAT THE EXTENDED PORTION OF THE COMBO BOLUS WAS NOT BEING DELIVERED BY THE REPORTED PUMP. THE PATIENT REPORTED HAVING ELEVATED BLOOD GLUCOSE LEVELS, SPECIFIC RESULTS NOT PROVIDED, AND ALLEGED THAT THE BOLUS WAS NOT BEING DELIVERED. A REVIEW OF THE PUMP HISTORY REVEALED ALL PROGRAMMED BOLUSES HAD BEEN DELIVERED. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    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 17 YR