BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULNI DELIVERY SYSTEM

    MDR report key: 3922139 · Received May 30, 2014

    Report

    Report Number
    3007981285-2014-00872
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING MOTHER INDICATED PUMP WAS PROVIDING OCCLUSION ALARMS, REPORTER MENTIONED PATIENT WAS RECENTLY CHANGED TO APIDRA. CUSTOMER TECHNICAL SUPPORT HAS NOTIFIED REPORTER THAT APIDRA INSULIN IS CONTRAINDICATED FOR USE WITH T: SLIM.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT WAS EXPERIENCING HIGH BG'S. AS PER MOTHER, SHE GAVE THE PATIENT SOME INSULIN INJECTIONS TO HELP BRING DOWN THE BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319752 TANDEM T: SLIM INSULNI DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR