BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2961909 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01780
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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 A LOW BLOOD GLUCOSE OF 40 MG/DL WITH MILD SHAKINESS. THE PATIENT REPORTED TREATING THE LOW WITH GLUCOSE TABS FOLLOWED BY EATING A MEAL. THE PATIENT REPORTED THAT BLOOD GLUCOSE LEVELS LATER ELEVATED TO 360 MG/DL WITH NO REPORTED SYMPTOMS WHICH THE PATIENT ATTRIBUTED TO EATING TOO MANY CARBOHYDRATE TO CORRECT FOR THE LOW BLOOD GLUCOSE. THE PATIENT STATED THAT SHE GAVE THE SUGGESTED AMOUNTS PER PUMP FOR BOLUSES. THE PUMP SETTINGS WERE REVIEWED AND WERE FOUND TO BE PROGRAMMED AS DESIRED. TROUBLESHOOTING OF THE PUMP FOUND NO EVIDENCE OF DEFECTS. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA OF UNCLEAR CAUSE WHILE USING THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66101 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening