BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4110367 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27117
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/12/2015 WITH THE FOLLOWING FINDINGS: THE LAST BASAL DELIVERY WAS ON (B)(6) 2014 AND THE LAST BOLUS DELIVERY WAS ON (B)(6) 2014. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECT USER'S PROGRAMMED BASAL RATES. TYPICAL USAGE OBSERVED IN ALARM HISTORY. A 10U NORMAL BOLUS AND A 10U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON KEYPAD. PUMP HISTORY FOUND TO BE RECORDING PROPERLY. NO EAW¿S OCCURRED DURING 24HR DURATION TESTING. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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 FOR EVALUATION. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING HISTORY SETTINGS ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 29 MMOL/L WITH FEELING IRRATIONAL. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THE BOLUS TOTALS MATCH AND THERE WERE MISSING BOLUS RECORDS. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591990 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening