BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3052474 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04063
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 17, 2013
    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 FOR EVALUATION. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT SHE IS UNABLE TO DELIVER A BOLUS AND THAT SHE WAS ABLE TO CHANGE THE LIMIT. CUSTOMER SUPPORT ASKED PATIENT TO CHECK THE TIME AND DATE AND THE DATE WAS (B)(6) 2007 AND STATED THAT SHE NOTICED THE TIME WAS SET TO AM AND IT IS NOW PM. THE PATIENT STATED THAT THE TIME AND DATE HAVE BEEN INCORRECT FOR AT LEAST A WEEK AND THAT WHEN SHE CHANGES THE BATTERY IT REVERTS TO (B)(6) 2007 12AM. THE PATIENT STATED THAT SHE HAS BEEN HAVING ISSUES WITH HER BLOOD GLUCOSE (BG) LEVELS BEING HIGH AND LOW THIS WEEK AND THAT HER LOWS SEEM TO BE OCCURRING AROUND 3-4 AM AND THE HIGHS ARE ALL DURING THE MIDDLE OF THE DAY. SHE STATED THAT HER BG ON (B)(6) 2013 WAS 40MG/DL WITH CONFUSION AND UNRESPONSIVENESS. SHE WAS TREATED BY HER HUSBAND LIME SODA AND THEN 3-4 HOURS LATER HER BG WAS AT 591MG/DL WITH REALLY FEELING NAUSEATED. SHE TREATED WITH CORRECTIONS VIA THE PUMP AND TOOK PHERNERGAN FOR THE NAUSEA AND BG DID RETURN TO TARGET. STATED THAT SHE NORMALLY DOES HAVE ISSUES WITH HER BG'S GOING HIGH AND LOW BUT HAS BEEN WORSE LATELY AND THINKS IT IS FROM THE TIME AND DATE BEING INCORRECT. THIS REPORT IS BEING MADE DUE TO THE ALLEGED BG EXCURSIONS THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156684 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening