BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3082148 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05462
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONTRIBUTORY AS THE IOB FEATURE HAD NOT BEEN TURNED ON. 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) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: PATIENT REPORTS THAT HE HAS NOTICED SINCE HIS IOB IS NOT SHOWING UP. IN RESPONSE, HE HAS BEEN GETTING LOWS OF ABOUT 32MG/DL TO HIGHS OF 400MG/DL. SYMPTOMS ONLY DURING LOWS OF SHAKY AND SWEATY. THE HIGHS ARE AS A RESULT OF FEAR THAT HE WILL DROP AND THUS UNDER BOLUSING. BG OF 400MG/DL, PATIENT BOLUSED; BG OF 32MG/DL PATIENT ATE CARBOHYDRATES. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED WITH PATIENT AND FOUND NO DEFECT WITH THE PUMP, BUT FOUND THAT THE IOB FEATURE WAS NOT TURNED ON. CTS INSTRUCTED PATIENT TO TURN ON IOB AND EDUCATED PATIENT ON USE OF FEATURE. THE PATIENT REMAINS ON PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USE ERROR CONTRIBUTED TO THE PATIENT EXPERIENCING HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184839 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening