BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222200 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10360
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/15/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/26/2013 WITH THE FOLLOWING FINDINGS:THE PUMP BLACK BOX SHOWED AN UNCONFIRMED ¿REPLACE BATTERY¿ ALARM ON 03/08/2013 ASSOCIATED WITH A LOW BATTERY VOLTAGE; THE PUMP EVENTUALLY ENTERED A CONTINUOUS REBOOT CYCLE WHEN THE BATTERY DEPLETED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR TESTING. A TEST CAP WAS INSERTED AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ISSUES. THE PUMP WAS OPENED AND NO DAMAGE OR INTERMITTENT CONNECTIONS WERE FOUND. NO POWER ISSUES WERE DUPLICATED DURING TESTING. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER INDICATED THAT THE PUMP WAS REBOOTING FOR SEVERAL MONTHS. THE PATIENT REPORTED THAT NOW THE PUMP WAS EMITTING MULTIPLE REPLACE BATTERY ALARMS EVEN AFTER CHANGING THE BATTERY MAKING REVIEW OF THE PUMP IMPOSSIBLE. 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
    322568 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR