BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3111569 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06347
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE CERTIFIED DIABETES EDUCATOR (CDE) CONTACTED ANIMAS STATING THAT THE PATIENT HAD BEEN TAKEN TO THE EMERGENCY ROOM ON (B)(6) 2013 AND THEN RETURNED TO THE HOSPITAL AND WAS ADMITTED ON (B)(6) 2013, WITH LOW BLOOD GLUCOSE (BG). THE PATIENT'S BASAL RATE WAS LOWERED AND THE INSULIN TO CARBOHYDRATE RATIO WAS REPORTEDLY CHANGED DUE TO THE LOW BGS. NO BG VALUES OR SIGNS OR SYMPTOMS WERE REPORTED. THE PATIENT WAS REPORTEDLY STILL IN THE HOSPITAL AS FOR (B)(6) 2013. CUSTOMER TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY SOUGHT MEDICAL INTERVENTION FOR HYPOGLYCEMIA OF UNKNOWN CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213064 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L| R