BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4083200 · Received September 11, 2014

    Report

    Report Number
    2531779-2014-25940
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON XX/XX/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA INDICATED UNEXPLAINED PUMP REBOOTS AND VOLTAGE FLUCTUATIONS. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT WITH NO DAMAGE; HOWEVER, EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE. THE BATTERY CAP SECURED PROPERLY TO THE PUMP, AND A POWER LOSS WAS NOT OBSERVED. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. A LEAK TEST WAS PERFORMED AND PASSED. THE PUMP CASE WAS REMOVED AND NO FURTHER EVIDENCE OF MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND.

    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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE. IT WAS REPORTED THAT EVIDENCE OF MOISTURE INGRESS WAS VISIBLE IN THE PUMP BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561752 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR