BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3223762 · Received July 10, 2013

    Report

    Report Number
    3007981285-2013-00035
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING CONVERSATION WITH CUSTOMER IT WAS IDENTIFIED THAT UNIT HAD MULTIPLE OCCLUSION ALARMS. INFUSION SET BEING USED AT THE TIME OF EVENT IS NOT ONE DISTRIBUTED BY TANDEM. FURTHER TROUBLESHOOTING INDICATED THAT OCCLUSIONS MIGHT BE RELATED TO PT SITES. PT INDICATED THAT THERE IS BLOOD AT EVERY SITE CHANGE AND HAS ALSO SEEN KINKING OF THE TUBING WHEN HE TOSSES AND TURNS IN BED. TANDEM HAS RECOMMENDED HE REACH OUT OT HIS HEALTH CARE PROVIDER. EVENT NOT LIKELY TO LEAD TO DEATH. T:SLIM USER GUIDE INSTRUCTS USERS TO "ROUTINELY CHECK THEIR BG LEVELS AT LEAST 4 TIMES DAILY (OPTIMALLY 6-8 TIMES DAILY) IN ORDER TO DETECT HYPERGLYCEMIA AND HYPOGLYCEMIA EARLY." ADDITIONALLY, T:SLIM USER GUIDE CAUTIONS USERS "TO INJECT INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON." IT IS COMMON PRACTICE FOR INSULIN USERS TO CHECK BLOOD GLUCOSE VALUES FREQUENTLY TO PREVENT LEVELS FROM BECOMING SEVERE ENOUGH TO CAUSE SERIOUS COMPLICATIONS.

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM THE PT INDICATING, HE HAD CHECKED INTO THE EMERGENCY ROOM WITH HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315052 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R