BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2192083 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05620
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: THE PUMP PASSED AN IN-HOUSE LEAK TEST; NO CORROSION OBSERVED INSIDE BATTERY COMPARTMENT. THE PUMP BOOTED TO THE 'VERIFY' SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY TONES. THE PUMP WAS EXERCISED FOR 24 HR WITHOUT INTERRUPTIONS. THE PUMP APPEARED TO BE RUNNING ON DEFAULT TIME/DATE SINCE (B)(6) 2011 ACCORDING TO TOTAL DAILY HISTORY. THE PUMP BLACKBOX INDICATED NO POWERLOSS EVENTS OCCURRED BETWEEN (B)(6) 2007 UNTIL END OF PUMP USE ON (B)(6) 2007. PUMP OPENED FOR FURTHER ANALYSIS; NO MOISTURE DAMAGE WAS OBSERVED INSIDE PUMP.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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 PATIENT CLAIMED THAT THE ANIMAS PUMP HAS POWER ISSUE. BACK IN (B)(6) 2010, THE SUBJECT PUMP POWERED OFF AFTER HE WAS IN A POOL WITH THE PUMP. THE PATIENT DOES NOT RECALL RECEIVING AN ALARM ON THE PUMP AT THE TIME OF CONCERN. THERE WAS NO WATER IN THE BATTERY COMPARTMENT OR CARTRIDGE COMPARTMENT. THE PATIENT IS FULLY INTACT WITH NO VISIBLE DAMAGE. THE PATIENT WAS ABLE TO REBOOT THE SUBJECT PUMP AFTER HE PUT A HAIRDRYER ON THE PUMP FOR 1-2 HOURS AND INSERTED THE BATTERY. REPORTEDLY, THE PATIENT DID NOT HAVE ANY POWER ISSUES EVER SINCE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE POWER ISSUE. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE.

    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 62 YR