BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162783 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08094
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS AT THIS TIME. 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 AN INCIDENT IN WHICH BLOOD GLUCOSE LEVELS DROPPED TO 20 MG/DL REQUIRING EMERGENCY MEDICAL ASSISTANCE AND HOSPITALIZATION. THE PATIENT REPORTED THAT DURING THE EVENT, THE PATIENT COULD FEEL BLOOD GLUCOSE LEVELS DROPPING RAPIDLY, FELT VERY DISORIENTED AND WAS ¿ACTING DRUNK.¿ THE PATIENT INDICATED THAT THEY DID NOT BELIEVE THAT THE LOW WAS CAUSED BY THE PUMP. THE PATIENT INDICATED HAVING A GREAT DEAL OF STRESS RECENTLY AND INDICATED RECENT WEIGHT LOSS. THE PATIENT REPORTED THAT THE HEALTH CARE PROVIDER ADVISED THE PATIENT NOT TO RESUME PUMP THERAPY UNTIL THE PATIENT CAN GAIN 10 LBS. THE PATIENT STATED THAT NO BOLUSES WERE DELIVERED LEADING UP TO THE LOW BLOOD GLUCOSE EVENT; THE TOTAL DAILY DOSE HISTORY CONFIRMED THAT ONLY BASAL RATE WAS DELIVERED. TROUBLESHOOTING OF THE EVENT INDICATED THAT THE PUMP APPEARED TO BE WORKING CORRECTLY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT REQUIRING MEDICAL ATTENTION WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262707 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L