BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4213890 · Received October 30, 2014

    Report

    Report Number
    2531779-2014-30888
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 280 MG/DL WITH ABDOMINAL PAIN/VOMITING, POLYDYPSIA, NAUSEA, SYMPTOMS OF DEHYDRATION AND RAPID, DEEP BREATHING/SHORTNESS OF BREATH AND/OR CHEST PAIN AND AN UNSPECIFIED LEVEL OF KETONES ASSOCIATED WITH A POWER ISSUE AND DAMAGE TO THE PUMP. IT WAS REPORTED THAT THE PATIENT DISCONTINUED PUMP THERAPY, AND SELF-TREATED WITH 12 UNITS OF INSULIN VIA SYRINGE WHICH BROUGHT THEIR BG TO 215 MG/DL. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REPORTED THAT THERE WAS DAMAGE TO THE BATTERY CAP AND MOISTURE/CORROSION OBSERVED INSIDE THE BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO NO POWER TO THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697546 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening