BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3200959 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09460
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 10/02/2013 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2013 WITH THE FOLLOWING FINDINGS: THE PUMP ALARM HISTORY SHOWED THAT AN OCCLUSION ALARM HAD OCCURRED PRECEDED BY A CONSTANT RISE IN FORCE. THE HISTORY SHOWED THAT THE PUMP DELIVERY WAS NOT RESUMED AFTER THE ALARM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS; NO OCCLUSION ALARMS OCCURRED DURING TESTING. A FORCE SENSOR CALIBRATION TEST CONFIRMED THAT THE FORCE SENSOR WAS WITHIN CALIBRATION. AN OCCLUSION WAS INDUCED DURING TESTING AND THE PUMP ALARMED APPROPRIATELY TO ALERT THE USER OF THE ISSUE. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    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.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVALUATION BY PRODUCT ANALYSIS SHOULD REFLECT 09/10/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: MOM REPORTS PT AWOKE TO PUMP ALARMING. THERE WAS NO CODE DISPLAYED ON SCREEN. MOM STATES SHE NEVER HEARD AN ALARM LIKE THIS. VERY LOUD AND PUMP WAS VIBRATING TOO. DISCONNECTED AND THEY ATTEMPTED TO REBOOT PUMP BUT , THE PUMP IMMEDIATELY STARTED WITH LOUD ALARM AGAIN. MOM THEN TRIED NEW BATTERY BUT AGAIN, PUMP STARTED ALARMING AS SOON AS VERIFICATION SCREEN WAS CONFIRMED. NO CODE DISPLAYED. NO EXPOSURE TO MOISTURE, MRI, X-RAY OR TRAUMA. PATIENT CHECKED BLOOD GLUCOSE DURING CALL, IT WAS 446 MG/DL AND PATIENT WAS VERY THIRSTY. CUSTOMER SUPPORT ADVISED THE PATIENT TO GO TO AN ALTERNATE DELIVERY PLAN AND PATIENT AGREES. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301670 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening