BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3854952 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16117
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA INDICATED TWO LOW BATTERY WARNINGS ASSOCIATED WITH THE SAME BATTERY, AND A CS 128-FE88 WAS FOUND IN THE DEVICE HISTORY; HOWEVER, NO EVIDENCE OF SHORT BATTERY LIFE WAS OBSERVED. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT WITH NO DAMAGE OR EVIDENCE OF MOISTURE INGRESS. THE BATTERY CAP SECURED PROPERLY TO THE PUMP, AND A POWER LOSS WAS NOT OBSERVED. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND. UNRELATED TO THE COMPLAINT, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED.

    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) ISSUE. IT WAS REPORTED THAT THE PUMP BATTERY LIFE DID NOT LAST AS LONG AS EXPECTED. THE BATTERY WAS CHANGED; HOWEVER, THE ISSUE OF SHORT BATTERY LIFE 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
    336563 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR