BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3254150 · Received July 24, 2013

    Report

    Report Number
    3007981285-2013-00039
    Event Type
    Other
    Date Received
    July 24, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER INVESTIGATION PATIENT INFORMED TANDEM THAT UNIT HAD PROVIDED THREE OCCLUSION ALARMS. PATIENT CLEARED THE FIRST TWO ALARMS AND APPARENTLY DID NOT HEAR THE THIRD ALARM. PATIENT WOKE UP WITH A BG OF 400 AND CHANGED OUT HER INFUSION SET AND CARTRIDGE. PATIENT SAW BLOOD IN THE CANNULA AND WAS BLEEDING FROM HER SITE INDICATING UNIT WORKED AS INTENDED. PATIENT WAS SEEN BY HER HEALTH CARE PROVIDER (HCP) WHO SENT HER TO THE HOSPITAL, WHERE THEY WERE ABLE TO GET HER BG LEVELS BACK WITHIN HER TARGET RANGE. USER GUIDE STATES; IF YOUR T: SLIM PUMP DETECTS INSULIN DELIVERY IS BLOCKED, THE OCCLUSION ALARM OCCURS AND ALL INSULIN DELIVERIES ARE STOPPED. CHECK THE CARTRIDGE, TUBING AND CANNULA TO HELP DETERMINE THE CAUSE. 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 PREVENT DKA OR A VERY HIGH BG, YOU MUST BE PREPARED 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 INFO FROM A TANDEMS SALES REP INDICATING A PATIENT WAS TAKEN TO THE HOSPITAL FOR HIGH BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344547 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization