BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2101859 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03675
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: 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 PUMP DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) FOR TWO TO THREE DAYS HAS BEEN FROM ABOUT 20 MG/DL TO ABOUT 400 MG/DL. THE PATIENT WAS TREATED FOR HYPOGLYCEMIA (TREATMENT UNKNOWN). ON (B)(6) 2011 HER BG AT 7:30AM WAS 420MG/DL. SHE TESTED HER BG BEFORE LUNCH AND IT WAS 40 MG/DL. AFTER SHE ATE LUNCH HER BG WAS 109MG/DL. SHE RECEIVED NO OTHER TREATMENT FOR THE HYPOGLYCEMIC OTHER THAN ORAL CARBOHYDRATES. THE FAMILY MEMBER HAS NO EXPLANATION FOR THE LOW BG. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S BG EXCURSIONS.

    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 6 YR