BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4131362 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-27998
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE LAST BOLUS DELIVERY AND THE LAST BASAL DELIVERY WERE ON (B)(6) 2014. NO ALARMS RELATED TO THE COMPLAINT WERE NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. THE BASAL AND BOLUSES ADDED UP APPROPRIATELY TO TOTAL THE TOTAL DAILY DOSES, SHOWING THAT THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND OPERATING WITHIN RANGE. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE COMPLAINT. 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, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH INACCURATE PUMP DELIVERY. THE REPORTER STATED THAT ON (B)(6) 2014, THE PATIENT'S BLOOD GLUCOSE (BG) WAS 554 MG/DL WITH NO KETONES AND SYMPTOMS OF NAUSEA, CHEST PAIN, AND RAPID DEEP BREATHING/SHORTNESS OF BREATH. IT WAS REPORTED THAT THE PATIENT RECEIVED UNSPECIFIED TREATMENT AND WAS HOSPITALIZED. REPORTEDLY, THE PATIENT'S HEALTHCARE PROVIDER HAD NOT MADE PUMP SETTING ADJUSTMENTS BEFORE OR AFTER THE ALLEGED EVENT AND THE PATIENT REMAINED ON THE PUMP. TROUBLESHOOTING DETERMINED THAT THE BASAL AND BOLUS TOTALS MATCHED THE PATIENT'S PROGRAMMED SETTINGS AND THAT THERE WERE NO OTHER CONTRIBUTING FACTORS REPORTED. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED PUMP USE FOR WHICH A PUMP MALFUNCTION COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610591 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R