BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201542 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09513
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/11/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. INFORMATION FROM THE REPORTED EVENT DATE IS OVERWRITTEN IN THE BLACK BOX; HISTORY DOWNLOAD SHOWS NO ACTIVITY OUTSIDE OF NORMAL USE. LAST BASAL DELIVERY WAS ON (B)(6) 2013. TDD ADD UP CORRECTLY AND REFLECT THE PROGRAMMED BASAL TARGET. THE PUMP PASSED ¿EZ-PRIME¿ STEPS AND IT WAS EXERCISED SUCCESSFULLY, THE PUMP WAS FOUND ABLE TO DISPLAY ¿DETACHED INFUSION SET FROM BODY¿ CLEARLY BEFORE EACH ¿PRIME¿ STEP. 3-FORCE SENOR CALIBRATION READING IS AT THE CORRECT COUNT. THE PUMP PASSED A 29H FLOW ACCURACY TEST SUCCESSFULLY. PUMP¿S COVER WAS REMOVED; INSPECTION SHOWS NO INTERMITTENT CONDITION TO THE FORCE SENSOR CIRCUIT. 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

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PUMP WAS PRIMED WHILE THE PATIENT WAS CONNECTED TO THE INFUSION SET. THE PATIENT REPORTED THAT THE MISTAKE WAS REALIZED IMMEDIATELY AND THAT HE RECEIVED AN UNKNOWN AMOUNT OF INSULIN. IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE WAS AS LOW AS 45MG/DL, EMERGENCY MEDICAL ASSISTANCE WAS REQUESTED, AND THE PATIENT RECEIVED GLUCAGON TO RESOLVE THE HYPOGLYCEMIA. THERE WAS NO ALLEGATION OF A PUMP MALFUNCTION OR DEFECT, NOR IS THE PUMP BEING RETURNED BECAUSE OF THIS INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ERRED BY REMAINING ATTACHED TO THE PUMP DURING THE PRIMING STEP AND EXPERIENCED HYPOGLYCEMIA BECAUSE OF THE MISTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303321 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention