BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3221106 · Received July 11, 2013

    Report

    Report Number
    2531779-2013-10321
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/28/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/17/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL DELIVERY WERE ON 07/03/2012. THERE WERE NO ALARMS OR ERRORS RELATED TO THE COMPLAINT IN THE BLACK BOX OR ALARM HISTORY, ONLY TYPICAL USAGE WAS OBSERVED. THE DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES SHOWING THE PUMP WAS DELIVERING ACCURATELY UP UNTIL THE LAST DATE USED BY THE PATIENT. A 29-HR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013 ANIMAS WAS NOTIFIED THAT THE PATIENT HAD BEEN HOSPITALIZED WHILE USING THE PUMP AND THE MD HAD REQUESTED THE PATIENT STOP USING THE PUMP. NO ADDITIONAL DETAILS WERE AVAILABLE AT THE TIME OF INITIAL CONTACT. ANIMAS WAS ABLE TO FOLLOW UP WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED THAT AT THE END OF (B)(6) 2012 SHE WAS HOSPITALIZED WITH ELEVATED BLOOD GLUCOSE (BG) OVER 600MG/DL. THE PATIENT STATED SHE HAD ATTEMPTED TO RESOLVED ELEVATED BGS ON HER OWN BUT AFTER THREE DAYS OF ELEVATED BGS AND A SYNC OPAL EPISODE, SHE WENT TO THE HOSPITAL. THE PATIENT COULD NOT PROVIDE SPECIFIC DETAILS REGARDING THE HOSPITALIZATION OR TREATMENT. THE PATIENT NOTED THAT SHE HAD FALLEN AND REQUIRED SURGERY FOR HER BACK. IT IS UNKNOWN IF THE FALL WAS RELATED TO THE ELEVATED BGS OR NOT. THE PATIENT WAS REPORTEDLY DISCHARGED ON (B)(6) 2012 AND WAS INSTRUCTED TO COME OFF THE PUMP. THE PATIENT HAD REPORTEDLY BEEN OFF THE PUMP SINCE THE REPORTED INCIDENT AND WANTED TO RETURN THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA OF UNKNOWN CAUSE REQUIRING MEDICAL INTERVENTION WHILE USING INSULIN PUMP THERAPY. IT IS UNKNOWN AT THIS TIME IF THE PUMP MAY HAVE BEEN A CAUSE OR CONTRIBUTOR IN THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320588 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R