BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3170200 · Received June 14, 2013

    Report

    Report Number
    2531779-2013-08237
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/30/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED NO ALARMS ASSOCIATED WITH THE COMPLAINT IN THE HISTORY. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. DURING TESTING, 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) 2013, THE REPORTER CONTACTED ANIMAS STATING THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE RANGE OF 300MG/DL TO 630MG/DL. THE PATIENT REPORTEDLY EXPERIENCED THE BG VALUE OF 630MG/DL ON THE NIGHT OF (B)(6) 2013. IT WAS NOTED THAT THE PATIENT DID NOT HAVE KETONES AND DID NOT HAVE SYMPTOMS. THE REPORTER STATED THAT THE PATIENT WAS TREATED WITH CORRECTIONS INJECTIONS AND BY BOLUSING WITH THE PUMP. THE REPORTER STATED THAT THE PUMP DID NOT SEEM TO BE ADDRESSING THE ISSUES WITH HIGH BGS. THE PATIENT REPORTEDLY HAS BEEN HAVING BG ISSUES FOR THE PAST 3 DAYS. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY AND THERE WERE NO DELIVERY ISSUES NOTED WITH THE PUMP. THERE WERE NO ISSUES NOTED WITH THE TOTAL DAILY DOSE. THIS COMPLAINT IS BEING REPORTED DUE THE PATIENT EXPERIENCING A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY AND DUE TO ALLEGATION THERE MAY HAVE BEEN A PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271996 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening