BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2153712 · Received July 7, 2011

    Report

    Report Number
    2531779-2011-04763
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(6).

    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 POWERS ON PROPERLY WITH NO MALFUNCTIONS. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED ON (B)(6) 2011, WHICH COULD NOT BE DUPLICATED ON INVESTIGATION. EVALUATION REVEALED THAT THE BATTERY CAP WAS ABLE TO SECURE TO THE PUMP APPROPRIATELY. THERE WAS EVIDENCE OF MOISTURE OBSERVED INSIDE THE BATTERY COMPARTMENT. THE COMPLAINT REGARDING POWER LOSS COULD NOT BE 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PUMP POWERED OFF DURING USE. THE POWER ISSUE WAS NOTICED IMMEDIATELY. THERE WERE NO ELEVATED BLOOD GLUCOSE LEVELS. THE FAMILY MEMBER DENIED WATER EXPOSURE AND DENIED THAT THE BATTERY CAP WAS LOOSE. THE FAMILY MEMBER REPORTED THE INSIDE OF THE PUMP AND ON THE BATTERY FELT STICKY.

    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 14 YR