BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3936936 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20207
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    July 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: MOISTURE WAS OBSERVED WITHIN THE BATTERY COMPARTMENT. NO DAMAGE WAS OBSERVED TO THE PUMP¿S BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP WAS ABLE TO PROPERLY SECURE TO THE PUMP. THE PUMP PASSED LEAK TESTING WITHOUT EVIDENCE OF LEAKS. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE EXCURSION WITHOUT SYMPTOMS DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412620 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR