BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2881983 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14925
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 01/23/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(4) 2012 AT 10:00PM. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORIES. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. NO ERRORS, ALARMS, OR WARNINGS OCCURRED DURING INVESTIGATION. NO DELIVERY DEFECTS WERE FOUND ON INVESTIGATION. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT HER BLOOD GLUCOSE (BG) HAS BEEN OVER 300MG/DL ALL DAY AND THAT HER BG AT THE TIME OF THE CALL WAS 373MG/DL WITH LETHARGY AND THIRST. THE PATIENT CONFIRMED ALL PUMP SETTINGS WERE CORRECT. TROUBLESHOOTING INDICATING BASAL AND BOLUS HISTORIES ADD UP CORRECTLY. THE PATIENT DENIED ANY NEW MEDICATIONS, NEW ACTIVITIES OR STRESSORS, AND DIET CHANGES. THE PATIENT CONFIRMED THAT THERE ARE NO ISSUES WITH THE INSULIN. A REVIEW OF THE PRIME HISTORY INDICATES THAT THE PATIENT IS CHANGING SITES PER INSTRUCTIONS FOR USE. THERE WERE NO RELATED ALARMS OBSERVED IN THE PUMP HISTORY. THE PATIENT DENIED ANY SITE ISSUES AND DEMONSTRATES SITE ROTATION. THERE WAS NO INDICATION OF A PUMP MALFUNCTION FOUND ON TROUBLESHOOTING. THE PATIENT CONTINUED ON INSULIN PUMP THERAPY AND THE PUMP IS NOT BEING RETURNED AT THIS TIME. THE PATIENT WAS ADVISED TO CONTACT HER HEALTHCARE PROVIDER ABOUT THE POSSIBLE NEED FOR SETTINGS ADJUSTMENTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA OF UNDETERMINED CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening