BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830622 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13550
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 18, 2012
    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):A REVIEW OF THE BLACK BOX SHOWS EVIDENCE OF REBOOTING. VISUAL INSPECTION REVEALED NO DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP WITH NO YELLOW O-RING SHOWING.

    Additional Manufacturer Narrative · 1

    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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.ANIMAS HAS RECEIVED THE PUMP INVOLVED WITH THE COMPLAINT BUT HAVE NOT COMPLETED INVESTIGATIONS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT AN INTERMITTENT POWER ISSUE WITH THE PUMP. THE REPORTER CLAIMED THERE WAS NO VISIBLE DAMAGE TO THE PUMP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THERE IS NO INDICATION THAT THE PUMP CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE INTERMITTENT POWER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    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 67 YR