BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3974694 · Received August 3, 2014

    Report

    Report Number
    2531779-2014-22158
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/07/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE USERS PROGRAMMED BASAL AND I:C RATIO SETTINGS OBTAINED FROM THE PUMP DOWNLOAD. AFTER 24 HOURS, THE PUMP WAS TURNED OFF AND THE BATTERY WAS REMOVED AND THEN REINSERTED IN ORDER TO STIMULATE A BATTERY REPLACEMENT. THE BASAL SETTINGS AND I:C RATIO REMAINED CORRECTLY PROGRAMMED IN THE PUMP SETTINGS WITH NO CHANGES OBSERVED. THE INITIAL COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE INITIAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE BUMPER PAD AND THE COVER. THE RETURNED BATTERY CAP WAS ABLE TO FULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BASAL AND INSULIN TO CARBOHYDRATE RATIO SETTINGS WERE RESET AFTER A BATTERY CHANGE. 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
    452536 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR