BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6481589 · Received April 11, 2017

    Report

    Report Number
    3007981285-2017-10297
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    February 25, 2017
    Report Date
    April 11, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN EXPECTED EMPTY CARTRIDGE ALARM OCCURS, THE PUMP WILL VIBRATE THEN MAKE AN AUDIBLE NOISE. TANDEM'S TECHNICAL SUPPORT EDUCATED THE USER THAT THE FIRST NOTIFICATION WILL VIBRATE SINCE THE USER SET THE ALARM SETTING TO VIBRATE, BUT IF THE ALARM IS NOT ACKNOWLEDGED IT WILL ESCALATE TO AN AUDIBLE NOTIFICATION UNTIL THE CARTRIDGE IS CHANGED. THE USER ACKNOWLEDGED; HOWEVER, INSISTED THAT THEY ARE ABLE TO SILENCE THE ALARMS. THE USER STATED THAT THIS MAY HAVE IMPACTED THEIR BLOOD GLUCOSE LEVEL; HOWEVER, THE USER COULD NOT PROVIDE A BG LEVEL. THE USER CHANGED THE CARTRIDGE AND DELIVERED A BOLUS TO ADDRESS BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261891 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other