BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983017 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22501
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/27/2014 WITH THE FOLLOWING FINDINGS: THERE WAS ONE OCCLUSION ALARM OBSERVED IN THE BLACK BOX; THE FORCE AT TIME OF OCCLUSION IS HIGH. DAILY INSULIN DELIVERY TOTALS APPEAR INCONSISTENT DUE TO TIME/DATE ISSUE. THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. FORCE SENSOR CALIBRATION TEST CONFIRMED SENSOR IS DETECTING CORRECT FORCE AT 5LBS. THE PUMP EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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 AN OCCLUSION ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 573MG/DL WITH ABDOMINAL PAIN/VOMITING AND WAS TAKEN TO THE EMERGENCY ROOM AND DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS TREATED WITH INSULIN VIA INJECTION AND IV FLUIDS. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED OCCLUSION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461053 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization