BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2962409 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01811
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/17/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/03/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES. THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE VISIBLE IN THE PUMP¿S HISTORY. THE METER WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE PUMP SETTINGS CONFIRMED THAT THE INSULIN TO CARB RATION WAS SET TO 1 UNIT PER 10 GRAMS. USING THE USER¿S SETTINGS, AN EZ CARB BOLUS WAS PERFORMED FOR 60 CARBS AT THE TARGET BG. THE PUMP CORRECTLY CALCULATED A 10 UNIT BOLUS. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, INDICATING THAT THE METER RECORDINGS ARE SHOWING THE INCORRECT DATE AND TIME. THE METER DATE AND TIME ARE SET VIA THE PUMP. THE PUMP DATE/TIME WERE POTENTIALLY INCORRECT. IT IS CURRENTLY UNKNOWN IF THE PUMP DATE AND TIME WERE SET CORRECTLY. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PUMP DATE AND TIME MAY HAVE BEEN INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65707 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR