BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3260466 · Received August 1, 2013

    Report

    Report Number
    2531779-2013-12279
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT HE SUFFERED FROM A CONDITION CALLED GASTROPARESIS AND HAS BEEN IN AND OUT OF THE HOSPITAL OVER THE LAST FEW MONTHS. HER LAST HOSPITAL VISIT WAS TWO WEEKS PRIOR TO CONTACTING ANIMAS. HE WAS TREATED FOR GASTROPARESIS AND HYPOGLYCEMIA. HE HAS HAD BLOOD GLUCOSE READING AS LOW AS 37-47 MG/DL AND WAS UNCONSCIOUS. HIS DOCTOR RECOMMENDED THAT SHE GOES TO A CONTINUOUS GLUCOSE MONITORING AND INSULIN PUMP IN ONE SYSTEM. THERE WAS NO EVIDENCE OF A PRODUCT DEFECT ASSOCIATED WITH THE REPORTED INCIDENTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS HOSPITALIZED AND TREATED FOR HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THE PATIENT¿S HYPOGLYCEMIC EPISODES ARE MOSTLY DUE TO HER GASTROPARESIS CONDITION AND NOT A PRODUCT MALFUNCTION, THE ANIMAS PUMP COULD NOT BE RULED OUT AS A CONTRIBUTOR TO THE REPORTED HYPOGLYCEMIC INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360780 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R