BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242339 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11675
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH A BLOOD GLUCOSE (BG) OF 1053 MG/DL. THE PATIENT STATED THAT SHE HAD A HEART ATTACK AND HER KIDNEYS SHUT DOWN. THE PATIENT STATED THAT SHE WAS TOLD BY THE HOSPITAL STAFF TO NEVER GO BACK ON THE PUMP AGAIN AS IT WAS NOT WORKING. THE PATIENT REFUSED TO DO ANY TROUBLESHOOTING OF PUMP. THE PATIENT STATED THAT SHE HAS PUT IT IN THE BOX AND DOES NOT WANT ANYTHING TO DO WITH IT. THE PATIENT STATED PRIOR TO ADMISSION HER BG HAD BEEN GOOD ON THE PUMP. THE PATIENT IS CURRENTLY USING INSULIN PENS. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343924 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization