BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2020560 · Received February 16, 2011

    Report

    Report Number
    2531779-2011-00503
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    December 29, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION OF THE PRODUCT REVEALED THAT THE PRIME HISTORY AND SUSPEND HISTORY WAS NOT SHOWING DATA CORRECTLY. A 10 UNIT "NORMAL BOLUS" WAS PERFORMED DURING INVESTIGATION AND WAS CORRECTLY CAPTURED IN THE PUMP HISTORY. A "SUSPEND" AND A "PRIME" WERE ALSO PERFORMED DURING INVESTIGATION. HOWEVER, THE PUMP HISTORY WAS OBSERVED TO BE OVERWRITTEN SO THAT ONLY THE LATEST SUSPEND AND PRIME WERE PRESENT. THE PUMP BLACK BOX DOWNLOAD DID NOT SHOW ANY ERRORS OR ALARMS. AN EEPROM CORRUPTION WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT THE PUMP'S PRIME HISTORY WAS ONLY HOLDING ONE RECORD. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1