BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072216 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02973
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE SELF-REBOOT ISSUE WITH THE ANIMAS INSULIN PUMP. THE REPORTER INDICATED THAT WHEN HE/SHE RESEATS THE BATTERY, THE PUMP CONTINUALLY CYCLES THROUGH A REBOOT MODE. THERE WAS NO EVIDENCE OF A PRODUCT MISUSE. THE BATTERY CAP AND O-RING IS IN GOOD CONDITION. THREE NEW BATTERIES WERE USED BUT THE ISSUE WAS NOT RESOLVED. THERE WAS NO REPORT OF SYMPTOMS OR MEDICAL INTERVENTION ASSOCIATED WITH THE PRODUCT 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 44