BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041452 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03811
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED THE LAST BASAL AND LAST BOLUS DELIVERY WAS ON (B)(6) 2013. THE HISTORY SHOWED A REPLACE CARTRIDGE ALARM ON (B)(6) 2013 AT 13:07; DELIVERIES RESUMED AT 14:14. REVIEW OF THE TOTAL DAILY DOSES SHOWED THAT THE TOTAL ADDED UP CORRECTLY ACCORDING TO THE USER¿S PROGRAMMED BASAL RATES. THE PUMP¿S HISTORY ONLY SHOWED TYPICAL USAGE ALARMS AND WARNINGS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING A HOSPITALIZATION FOR A BLOOD GLUCOSE OF 700 MG/DL. THE PATIENT REPORTED BEING DISCONNECTED FROM THE PUMP FOR A COUPLE HOURS FOR AN MRI AND AFTER THE MRI THE PATIENT WAS EXPERIENCING CONFUSION AND LARGE KETONES WITH A BLOOD GLUCOSE OF 700 MG/DL. THE PUMP WAS REVIEWED WITH THE PATIENT AND FOUND THAT THE PUMP SETTINGS WERE CORRECT, THERE WERE NO ALARMS RELATED TO THE EVENT, AND THERE WERE NO ISSUES FOUND IN THE PUMP HISTORY RELATED TO THE EVENT. THE PATIENT REPORTED THAT DURING THE HOSPITALIZATION THEY FOUND THAT THE PATIENT WAS NEWLY PREGNANT BUT THERE WERE NO KNOWN CHANGES IN THE WEIGHT, DIET, OR INSULIN REGIME AT THE TIME. THE PATIENT REPORTED THAT AFTER TREATMENT BLOOD GLUCOSE LEVELS RESOLVED TO 120 MG/DL AND THE PATIENT CONTINUED ON THE PUMP. THIS REPORT IS MADE BASED ON THE CONCLUSION THAT THE PUMP COULD NOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143809 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L