BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4193339 · Received October 22, 2014

    Report

    Report Number
    2531779-2014-30008
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 11/11/2014 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE REPORTED COMPLAINT. THE LAST BASAL DELIVERY WAS ON (B)(6) 2014 AND THE LAST BOLUS WAS ON (B)(6) 2014. PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE; NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, REPORTER CONTACTED ANIMAS AND ALLEGED AN INACCURATE DELIVERY ISSUE WITH THE PUMP THAT LED TO THE PATIENT HAVING ERRATIC BLOOD GLUCOSE (BG) LEVELS: BGS IN 30MG/DL OCCURRED WITH SYMPTOMS OF HEART POUNDING, SWEATING, SHAKING. BGS BETWEEN 200-500MG/DL OCCURRED WITH SYMPTOMS OF NAUSEA, THIRST, AND MOODINESS. THE PATIENT REMAINED ON THE PUMP AND SELF-TREATED WITH FOOD. DRINK, AN INFUSION SET CHANGE, AND INSULIN VIA THE PUMP. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND PATIENT HAD A POSSIBLE HORMONAL CONDITION WHICH MAY HAVE BEEN AFFECTING THE BG LEVEL. CS REVIEW OF THE PUMP FOUND NO POTENTIAL CAUSES OF THE PERCEIVED INACCURATE DELIVERY ISSUE, BUT ADVISED PATIENT TO DISCONTINUE PUMP USE. THOUGH TROUBLESHOOTING DID NOT REVEAL ANY DELIVERY ISSUES, THE PATIENT DISCONTINUED PUMP THERAPY BECAUSE OF AN ALLEGED INACCURATE DELIVERY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP CANNOT BE RULED OUT AS CAUSING/CONTRIBUTING TO THE BLOOD GLUCOSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671231 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening