BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4821940 · Received June 5, 2015

    Report

    Report Number
    2531779-2015-18775
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/15/2015: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING RESULTS: BATTERY COMPARTMENT CRACK FOUND BELOW GRIP PAD TO THE CASE SEAL. UNABLE TO DUPLICATE THE COMPLAINT. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. THE LAST BASAL DELIVERY AND THE LAST BOLUS DELIVERY WERE ON (B)(6) 2015. PUMP BOOTS TO THE VERIFY SCREEN WITH NO ISSUES. A REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY WITH NO ERRORS OR ALARMS. THE PUMP CLEARLY DISPLAYS MESSAGE ¿DISCONNECT INFUSION SET FROM YOUR BODY!" ON THE REWIND SCREEN AND ¿BE SURE SET IS DISCONNECTED FROM YOUR BODY. THEN SELECT CONTINUE" ON THE PRIME SCREEN. 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 40 MG/DL, NO SYMPTOMS, AFTER AN INADVERTENT INFUSION THAT DAY. THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPOGLYCEMIA SUBSEQUENT TO THE USE ERROR OF AN INADVERTENT INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365018 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening