BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3953069 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21132
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 12, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/30/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA INDICATED EVIDENCE OF A VOLTAGE DROP. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT; HOWEVER, EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE THE COMPARTMENT. THE BATTERY CAP SECURED PROPERLY TO THE PUMP. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF FURTHER MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) ISSUE. IT WAS REPORTED THAT THE PUMP BATTERY LIFE DID NOT LAST AS LONG AS EXPECTED. THE BATTERY WAS ALLEGEDLY CHANGED; HOWEVER, THE SHORT BATTERY LIFE ISSUE RECURRED. 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
    431067 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR