BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1941779 · Received December 21, 2010

    Report

    Report Number
    2531779-2010-03020
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THERE IS NO INDICATION OF A PUMP MALFUNCTION. OCCLUSION ALARMS MAY HAVE EMITTED APPROPRIATELY DUE TO BLOCKAGE AND NOT A PUMP MALFUNCTION. THERE WERE NO ALARMS IN THE PUMP HISTORY LEADING UP TO THE HOSPITALIZATION, THEREFORE THE OCCLUSION ALARMS DID NOT CAUSE THE HOSPITALIZATION.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA. THE PT HAD BEEN RECOVERING FROM PNEUMONIA FOR THE PAST MONTH PRIOR TO CALLING ANIMAS. THE PT'S MOTHER STATED THAT THE NURSING STAFF CHANGED OUT THE CARTRIDGE AND SITE AND THE PUMP CONTINUED TO EMIT OCCLUSION ALARMS. THE PT'S MOTHER MENTIONS A HISTORY OF OCCLUSION ALARMS WITH THE PUMP.

    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 16 YR