BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083063 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03272
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    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 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 FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT RECEIVED MEDICAL TREATMENT AFTER THE PATIENT HAD A HYPOGLYCEMIC EPISODE AND LOSS CONSCIOUSNESS. REPORTEDLY, THE PATIENT HAD INCREASED ACTIVITY OVER THE PAST WEEK AS SHE HAS BEEN STAYING IN A REHAB FACILITY TO LEARN HOW TO USE A NEW PROSTHETIC. ON THE DAY OF CONCERN, THE PATIENT TESTED AT "300 MG/DL" AT 5:40 PM AND USED THE EZCARB FEATURE ON THE ANIMAS PUMP TO BOLUS HER INSULIN. AT 9 PM, THE PATIENT RECALLS HAVING A CUP OF COFFEE AFTER DINNER. THE NEXT THING SHE REMEMBERS, THERE WAS MEDICAL PERSONAL AROUND HER TRYING TO CHECK HER BLOOD GLUCOSE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND REMOVED FROM THE ANIMAS PUMP. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: REVIEW OF PUMP SETTINGS ALL AS EXPECTED- BASAL, INSULIN TO CARB RATIO, ISF, TARGET. TIME IS CORRECT IN THE PUMP; HOWEVER, THE DATE IS OFF BY ONE DAY. BOLUS HISTORY CONFIRMS THE LAST BOLUS WAS DELIVERED USING EZCARB FEATURE JUST BEFORE DINNER AT 5:40P BEFORE THE LOW BG OCCURRED AROUND 9P. THERE WERE NO ALARMS FROM PUMP. PATIENT DID NOT PRIME THE PUMP FOR ANY REASON. THERE WERE NO INFUSION SET ISSUES IDENTIFIED NOR ALCOHOL CONSUMPTION. SHE DOES NOT FEEL THE INCREASED ACTIVITY IS STRENUOUS ENOUGH TO CAUSE HYPOGLYCEMIA. THERE WAS NO DEFECT FOUND WITH THE ANIMAS INSULIN PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR A HYPOGLYCEMIC EPISODE WHILE MANAGING HER DIABETES WITH THE ANIMAS INSULIN PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Hospitalization| L| R