BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2131669 · Received June 16, 2011

    Report

    Report Number
    2531779-2011-04236
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 18, 2011
    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

    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.

    Description of Event or Problem · 1

    THE PATIENT STARTED ON INSULIN PUMP TREATMENT ON (B)(6) 2011. HIS DOCTOR BEGAN HIS BASAL RATE AT 2 UNITS PER HOUR AND SLOWLY ADJUSTED HIS BASAL RATE ACCORDINGLY. ON (B)(6) 2011, THE PATIENT WAS INVOLVED IN A BIKE CRASH. HIS BASAL RATE WAS AT 1 UNIT PER HOUR ON THE DAY OF CONCERN. AFTER THE PATIENT RECEIVED MEDICAL INTERVENTION WITH IV GLUCOSE AT THE EMERGENCY ROOM ON (B)(6) 2011 AND WAS RELEASED 3 HOURS LATER, HIS BASAL RATE ONCE AGAIN WAS REDUCE TO 0.8 UNIT PER HOUR. THE PATIENT ADMITTED THAT HE FORGETS TO BOLUS AND IS HAVING PROBLEMS WITH COUNTING CARBOHYDRATE. THE PATIENT STATES THAT SINCE THE BASAL RATE HAS BEEN REDUCED TO 0.8 UNIT HIS BLOOD GLUCOSE HAS BEEN IMPROVED. THE PATIENT DID NOT WANT TO REVIEW THE SETTINGS IN THE ANIMAS PUMP AND TROUBLESHOOTING WAS NOT COMPLETED. THE PATIENT REPORTEDLY IS ENROLLED IN (B)(6) TO BETTER MANAGE HIS DIABETES. THE PATIENT RECEIVED MEDICAL INTERVENTION SUGGESTIVE FOR HYPOGLYCEMIA WHILE HE MANAGED HIS DIABETES WITH THE ANIMAS PUMP. ALTHOUGH THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION, FACTORS SUCH AS THE REDUCTION TO PATIENT'S BASAL INSULIN STRONGLY SUGGESTS THE PATIENT WAS NOT USING THE CORRECT AMOUNT OF INSULIN AT THE TIME OF THE HYPOGLYCEMIC EPISODE. IN ADDITION, THE PATIENT REPORTEDLY IS NOT WELL VERSED IN COUNTING CARBOHYDRATE TO ADMINISTER THE PROPER AMOUNT OF INSULIN. HENCE, THIS COMPLAINT IS BEING REPORTED POSSIBLY DUE TO USER ERROR.

    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 55 YR Hospitalization| L| R