BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103159 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06114
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A BLACK BOX REVIEW SHOWS NO ACTIVITY OUTSIDE OF NORMAL USE, NO DRASTIC VOLTAGE DROPS IS OBSERVED. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PUMP PASSES ¿EZ-PRIME¿ STEPS AND EXERCISES CORRECTLY. THERE WAS NO ALARMS OR OVERHEATING DUPLICATED DURING THE TEST. BATTERY CAP AND COMPARTMENT ARE INTACT AND ABLE TO FIT SECURELY. ALL CURRENT DRAWING WERE FOUND WITHIN THE SPECIFICATIONS. THE PUMP WAS OPENED AND INSPECTED, NO MOISTURE INGRESS WAS FOUND TO THE PCB. THE POWER CIRCUIT AND THE POWER FLEXES WERE INSPECTED FOR INTERMITTENT CONDITION, NONE WAS FOUND. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THE REPORTER STATED THE BATTERY AND PUMP BECAME "EXTREMELY HOT." 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
    204200 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR