BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2031033 · Received March 16, 2011

    Report

    Report Number
    2531779-2011-01596
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REPORTED THAT HE REQUIRED PUMP SETTING ADJUSTMENTS TO PREVENT HYPOGLYCEMIA. AT THE TIME OF THIS REPORT, THE PT HAD NOT MET WITH HIS PHYSICIAN AND THE ADJUSTMENTS HAD NOT YET BEEN MADE. THE PT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AND/OR ADD'L INFO IS MADE KNOWN, AN EVAL 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 PT REPORTED THAT HE LOST CONSCIOUSNESS DUE TO HYPOGLYCEMIA; THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS NOT KNOWN. HE REPORTED THAT HE WOKE UP ON HIS OWN AND HIS BLOOD GLUCOSE WAS 58MG/DL. THE PT STATED THAT HE TREATED HIMSELF WITH GLUCOSE TABS AND OTHER ORAL CARBOHYDRATES. HE DENIED THE NEED FOR MEDICAL INTERVENTION. THE PT NOTED THAT HE HAS BEEN EXPERIENCING RECURRENT LOW BLOOD GLUCOSE VALUES IN THE MORNINGS, HE SOMETIMES FEELS EXTRA TIRED IN THE MORNING, AND HE TREATS HIMSELF AUTOMATICALLY WITH ORAL CARBOHYDRATES. HE STATED THAT HE SOMETIMES OVER-CORRECTS HIS LOW BLOOD GLUCOSE AND LATER HAS HIGH BLOOD GLUCOSE. THE PT SAID THAT ON ANOTHER OCCASION HE WOKE UP WITH A LOW BLOOD GLUCOSE (VALUE IS UNK), ATE A PIECE OF CAKE, AND RECHECKED HIS BLOOD GLUCOSE AT 300 MG/DL. AGAIN, HE SAID, THERE WAS NO MEDICAL INTERVENTION. THE PT REPORTED THAT HE IS IN THE MIDDLE OF REVISING THE PUMP PROGRAMMING WITH HIS HEALTH CARE PROFESSIONAL AND DOES NOT ALLEGE THAT THE PUMP MALFUNCTIONED. THE PT DECLINED TO REVIEW THE PUMP OR THE SEQUENCE OF EVENTS THAT LED TO THE HYPOGLYCEMIC EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP COULD NOT BE REVIEWED OR INVESTIGATED; THE CAUSE OF THE HYPOGLYCEMIC EVENT COULD NOT BE CONFIRMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention