BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2062659 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02474
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BLACK BOX STARTS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT ON (B)(6) 2011 HAVE BEEN OVERWRITTEN. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOWS NO EAW¿S RELATED TO THE COMPLAINT. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECT THE USER PROGRAMMED BASAL RATE. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT, INFORMATION FOR THE COMPLAINT IS OVERWRITTEN.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PT HAD ISSUES WITH HIGH BLOOD GLUCOSE OF OVER "500 MG/DL" LAST EVENING. REPORTEDLY, THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. THE REPORTER PROVIDED SOME CIRCUMSTANCES THAT COULD HAVE EXPLAINED HIS HYPERGLYCEMIC BLOOD GLUCOSE. THE PT ALLEGEDLY WAS UNDER HIGH STRESS WITH HIS DOG THAT WENT MISSING WITHIN THE LAST 24 HOURS. IN ADDITION, THE PT HAD ONSET OF THE ALLERGY AND A SKIN INFECTION NEAR HIS EYE. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE PROVIDER CONCLUDED THAT THE ANIMAS PUMP WAS WORKING ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY HAD HYPERGLYCEMIC BLOOD GLUCOSE WHILE USING THE ANIMAS INSULIN PUMP TO MANAGE HIS DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening