BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3884206 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17612
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HOSPITALIZATION FOR A BLOOD GLUCOSE OF 335 MG/DL WITH NAUSEA/VOMITING AND DROWSINESS ASSOCIATED WITH AN ALLEGATION THAT THE PUMP MAY HAVE BEEN DELIVERING INACCURATELY. THE PUMP WAS REVIEWED WITH THE REPORTER AND FOUND THAT THE PUMP BASAL AND BOLUS SETTINGS WERE CORRECT, THE BASAL DELIVERIES REFLECTED THE PROGRAMMED RATES, THE BASAL TOTALS MATCHED THE TOTAL DAILY DOSE BASAL, THE BOLUSES RECORDED WERE ALL AS PROGRAMMED, AND THE BOLUS TOTALS MATCHED THE TOTAL DAILY DOSE BOLUS TOTAL. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA ASSOCIATED WITH THE ALLEGATION OF A PUMP DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359986 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| L