BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221240 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10333
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/11/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/25/2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. NO DEFECT WAS FOUND. A 29HR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. 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

    ON (B)(6) 2013, THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT'S BLOOD GLUCOSE (BG) IS 561 MG/DL, WITH MILD NAUSEOUS. MOM STATES SHE BELIEVES THAT PATIENT GAVE ALL BOLUSES AS INTENDED. PATIENT TOOK A PHENERGAN FOR THE NAUSEA AND MOM GAVE A CORRECTION BOLUS VIA PUMP. MOM REPORTS PUMP HISTORY DOES NOT RECORD ABOUT EVERY BOLUS. CUSTOMER SUPPORT (CS) ADVISED MOM TO DISCONTINUE PUMP UNTIL REPLACEMENT PUMP ARRIVES, TO USE AN ALTERNATE FORM OF INSULIN DELIVERY, AND TO CALL BACK IF BG DOES NOT COME DOWN. THIS COMPLAINT IS BEING REPORTED AS A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320141 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening