BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001734 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02653
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BASAL HISTORY SHOWS ON (B)(4) 2013 17:35 A 0.00U BASAL RATE WAS PROGRAMMED UNTIL (B)(4) 2013 17:35. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (THE REPORTER COULD NOT RECALL THE CAUSE BUT NOT IMPLICATING THE PUMP).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) WAS HIGH BLOOD GLUCOSE (BG) OF 400-500MG/DL WITH NAUSEA AND VOMITING FOR THREE TO FOUR HOURS. THE PATIENT WAS KEPT IN THE ER, GIVEN IV FLUIDS AND KEPT ON THE PUMP. THE PATIENT RECEIVED A BOLUS WITH THE PUMP AND WAS SENT HOME WHEN THE BG CAME DOWN TO 180MG/DL. THE REPORTER CONFIRMED THAT ALL ADVANCE BOLUS SETTINGS WERE CORRECT AND THERE WERE NO ALARMS GOING OFF AND HISTORY SCREENS WERE ACCURATE, NO MISSING INSULIN. THE REPORTER (ALSO THE FATHER) STATED THAT THEY FIGURED OUT WHY THE PATIENT WAS GOING HIGH BUT COULD NOT RECALL WHAT THE CAUSE WAS BUT BELIEVED THAT IT DOES NOT HAVE TO DO WITH THE PUMP. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM A CAUSE THAT THE REPORTER COULD NOT RECALL BUT THERE WAS NO IMPLICATION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105519 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization