BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120151 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06694
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 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 DATE OF SUBMISSION 07/24/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/25/2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED MULTIPLE ALARMS AND WARNINGS BUT NO REBOOTS. AN INSPECTION OF THE PUMP SHOWED NO PHYSICAL DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO TIGHTEN ON TO THE PUMP SECURELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS. THE PUMP WAS OPENED AND NO INTERNAL DAMAGE OR MOISTURE WAS FOUND ON THE INTERNAL CIRCUIT BOARD. THE PROCESSOR WAS ABLE TO BE LOADED WITH A NEW SOFTWARE CODE.

    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 POWER (NO POWER) ISSUE. THE REPORTER STATED THAT THE PUMP WAS UNABLE TO POWER ON AFTER MULTIPLE BATTERY CHANGES. THE REPORTER DENIED ANY VISIBLE DAMAGE TO THE PUMP. 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
    222562 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR