BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6322559 · Received February 10, 2017

    Report

    Report Number
    3007981285-2017-03268
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 20, 2017
    Report Date
    February 10, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017: DURING FOLLOW-UP, THE CUSTOMER REPORTED THAT THEY ARE USING THEIR REPLACEMENT PUMP AND HAVE NOT ENCOUNTERED ANY ISSUES. THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Additional Manufacturer Narrative · 1

    FILL ESTIMATE: 3367.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 150 - 457 MG/DL AND CORRECTION BOLUSES WERE DELIVERED TO ADDRESS THE BG LEVEL. AFTER THE FIRST OCCLUSION ALARM, THE CUSTOMER CHANGED THEIR INFUSION SET AND RESUMED INSULIN DELIVERY. THE CUSTOMER THEN RECEIVED ANOTHER OCCLUSION ALARM WHILE TRYING TO DELIVER A BOLUS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER LOADED A NEW CARTRIDGE AND RECEIVED A MINIMUM FILL ESTIMATE. IT WAS CONFIRMED THAT THE CUSTOMER WILL USE MANUAL INJECTIONS FOR DIABETES MANAGEMENT UNTIL THE REPLACEMENT PUMP ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104991 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017715

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other INFUSION SET: CLEO 90, INSULIN: NOVOLOG