BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2172269 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05119
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS FOUND TO BE STRIPPED AND WOULD NOT HOLD POWER TO THE PUMP. A TEST CAP WAS INSERTED AND THE PUMP BOOTED TO THE VERIFY SCREEN. NO ALARMS RELATED TO THE COMPLAINT WERE OBSERVED IN THE PUMP HISTORY. THE BLACK BOX HISTORY SHOWED INTERMITTENT REBOOTING WITH TIME AND DATE RESETS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT REBOOTING OCCURING. THE PUMP WAS POWERED OFF FOR ONE HOUR AND POWERED ON AND THE PUMP DID NOT MAINTAIN THE PROGRAMMED TIME AND DATE. UNRELATED TO THE COMPLAINT, DURING TESTING A LEAK TEST WAS PERFORMED ON THE PUMP AND THE BATTERY COMPARTMENT WAS FOUND TO BE LEAKING. THE PUMP WAS OPENED AND A LEAKING INTERNAL BATTERY ON THE PCB WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PUMP REBOOTED WITHOUT USER INTERVENTION. IT WAS NOTED THAT THERE WAS VISIBLE CORROSION IN THE BATTERY COMPARTMENT AND THAT THE BATTERY CAP HAD NEVER BEEN REPLACED. THE OWNER'S BOOKLET STATES THAT THE BATTERY CAP NEEDS TO BE REPLACED EVERY SIX MONTHS. ALTHOUGH THE BATTERY CAP WAS NEVER REPLACED THE USER WAS ABLE TO TIGHTEN THE BATTERY CAP TO RESISTANCE. THE USER SAID THERE WAS NO STRUCTURAL DAMAGE VISIBLE TO THE BATTERY COMPARTMENT. THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR