BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3161623 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08051
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 07/31/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/08/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX REVIEW SHOWS EVIDENCE OF DRASTIC VOLTAGE DROPS ON 05/16/2013 AFTER A TWO HOUR STUCK OF VP LEADING TO A ¿LOW BATTERY¿ WARNING. A DISCHARGED REPLACE BATTERY WAS RETUNED. A NEW BATTERY WAS USED, PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. THE PUMP WAS PRIMED AND EXERCISED, NO ALARMS OR OVERHEATING OCCURRED DURING TESTING. 3-EXTERNAL POWER SUPPLY WAS USED, ALL CURRENTS DRAWING WERE FOUND WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND INSPECTED, NO INTERMITTENT CONDITION OR MOISTURE WAS FOUND TO THE POWER CIRCUIT OR FLEX.

    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 PUMP WAS WARM TO THE TOUCH, AND THE BATTERY WAS HOT UPON REMOVAL. 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
    262655 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR