BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3902410 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18612
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. USER ERROR SHOULD BE CONSIDERED, AS THE PATIENT FAILED TO ADDRESS THE TOTAL DAILY DOSE LIMIT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/22/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/27/2016 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT,AS THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN.THE BLACK BOX STARTS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. NO ALARMS DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN HAS A PINKISH CONTRAST. AND THE BATTERY COMPARTMENT IS CRACKED ABOVE AND BELOW THE BUMPER PAD. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 538 MG/DL, FELT BAD, AND HAD SYMPTOMS OF DEHYDRATION. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND THAT, DUE TO A BENT CANNULA, THE PUMP HAD HIT THE TOTAL DAILY DOSE LIMIT AND THE PATIENT DID NOT CONTACT CS FOR ASSISTANCE IN RESUMING INSULIN DELIVERY. NO PUMP MALFUNCTION WAS IDENTIFIED. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA SUBSEQUENT TO USE ERROR OF NOT ADDRESSING THE TOTAL DAILY DOSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380160 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening