BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970947 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21950
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 18, 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 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2014 WITH THE FOLLOWING FINDINGS: LOW BATTERY WARNINGS AND A REPLACE BATTERY ALARM OBSERVED IN THE BLACK BOX. SHORT BATTERY LIFE OBSERVED IN THE PUMP HISTORIES. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE WITHIN SPECIFICATIONS. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OVER 580 MG/DL WITH LETHARGY AND IRRITABILITY. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) DETERMINED THAT THE PUMP HAD A POWER/BATTERY LIFE ISSUE THAT HAD OCCURRED WITH 3 SEPARATE BATTERIES FROM AT LEAST 2 SEPARATE PACKS. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE POWER ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447453 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening