BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3900318 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00556
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING MOTHER INDICATED INFUSION SITE IS NOT ALWAYS CHANGED, ALSO REPORTED SHE HAS BEEN CHANGING DAUGHTERS PERSONAL PROFILE SETTINGS TO SEE WHAT SETTINGS WORK BEST FOR HER DAUGHTER. CUSTOMER TECHNICAL SUPPORT ASKED REPORTER TO DOWNLOAD PUMP LOGS. LOGS WERE DOWNLOADED AND MOTHER INDICATED THERE WERE MULTIPLE ALARMS AND REPORTER DID NOT KNOW WHAT SOME OF THE ALARMS MEANT. CTS EXPLAINED WHAT THE ALARMS WERE. NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING HIGH BG'S (-300'S MG/DL). AS PER REPORTER PUMP WAS BEING USED FOR BOLUS CALCULATIONS. BOLUS DELIVERIES ARE VIA SYRINGE RATHER THAN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268100 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002503

    Patients

    Seq Age Sex Outcome Treatment
    1 28 MO