BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4820255 · Received June 4, 2015

    Report

    Report Number
    2531779-2015-18657
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    May 20, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/06/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED THAT THE RECORDED TOTAL DAILY DOSE VALUES ACCURATELY REFLECTED THE PROGRAMMED BASAL RATES. A DELIVERY ACCURACY TEST WAS PERFORMED AND PASSED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO OBSERVED ERRORS, ALARMS, OR WARNINGS. THE COMPLAINT WAS NOT DUPLICATED, AND NO DEFECT WAS FOUND.

    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

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTING S (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE USER BLOOD GLUCOSE (BG) READINGS WERE AT OR BELOW 70 MG/DL AS WELL AS ABOVE 250 MG/DL; HOWEVER, THE READINGS DID NOT REACH BELOW 40 MG/DL, NOR DID THEY EXCEED 500 MG/DL. THERE WERE NO REPORTED SYMPTOMS ASSOCIATED WITH HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR WAS THERE A REPORT OF ASSISTANCE BY A THIRD PARTY, LOSS OF CONSCIOUSNESS, POSITIVE KETONES, OR SEIZURE. THE ALLEGED BG EXCURSION DOES NOT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY AND IS THEREFORE NOT REPORTABLE AS AN ADVERSE EVENT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A HISTORY/SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362144 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR