BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3000266 · Received March 12, 2013

    Report

    Report Number
    2531779-2013-02624
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: . UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. NO DEFECT FOUND. THE ACCESSIBLE BLACK BOX AND ALARM HISTORY SHOWS NO ALARMS ASSOCIATED WITH THE COMPLAINT. THE TOTAL DAILY INSULIN DELIVERIES ADD UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. PUMP SUCCESSFULLY PASSED A 29HR FLOW ACCURACY TEST. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A BLOOD GLUCOSE AS LOW AS 45 MG/DL WITH WEAKNESS AND DIFFICULTY SPEAKING. THE PATIENT REPORTED NOT WANTING TO REVIEW THE PUMP AS THE PATIENT ADJUSTS THE RATES ALL THE TIME. THE PATIENT REPORTED BEING SICK FOR SOME TIME AND HAD A SURGERY COMING UP SOON. THE PATIENT REPORTED BEING LESS ACTIVE THAN USUAL AND STATED THAT DIET HAS BEEN DIFFERENT DUE TO MEDICATIONS AND ACTIVITY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH THE PATIENT SELF ADJUSTING INSULIN RATES WITHOUT THE SUPERVISION OF A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103333 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening