BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242073 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32120
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 01/29/2015 ¿ DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/16/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT NO ERRORS, ALARMS, OR WARNINGS RELATED TO THE COMPLAINT WERE RECORDED. THE PUMP¿S DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER¿S PROGRAMMED BASAL RATES. A DELIVERY ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE BUMPER PAD AND COVER. NO CARTRIDGE CAP WAS RETURNED WITH THE PUMP. A TEST CARTRIDGE CAP AND THE RETURNED BATTERY CAP WAS USED TO COMPLETE ALL TESTING. THE COMPLAINT THAT THE PUMP WAS DELIVERING INSULIN INACCURATELY WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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 A HISTORY/SETTINGS (INACCURATE DELIVERY) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS DELIVERING INSULIN INACCURATELY. IT WAS NOTED THAT ADVANCED BOLUS FEATURES WERE BEING USED. THE INDICATED BLOOD GLUCOSE (BG) BELOW 70 MG/DL BUT GREATER THAN 40 MG/DL WITH NO SIGNS OR SYMPTOMS WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. 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
    721923 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR