BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133875 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28117
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 29, 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

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON WITH VIBRATORY AND AUDIBLE SOUNDS. PUMP WAS EXERCISED FOR 24HRS, NO 0.00U BOLUSES WERE RECORDED IN HISTORY DURING THIS TIME. INVESTIGATORS SUCCESSFULLY PERFORMED A NORMAL 10U BOLUS AND A 10U AUDIO BOLUS. BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON THE KEYPAD. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE PUMP HISTORY. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A HISTORY SETTINGS ISSUE. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP AND BASAL AND BOLUS SETTINGS MATCH. THE BOLUSES ARE NOT BEING RECORDED CORRECTLY. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 25MMOL/L WITH EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION, IRRITABILITY, FLUSHED, COMBATIVENESS, AND TRACE TO SMALL KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT RECEIVED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610845 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening