BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3812707 · Received May 5, 2014

    Report

    Report Number
    3007981285-2014-00540
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING A CARTRIDGE ALARM 1 AND 19 DURING LOAD/BOLUS DELIVERY. THE REPORTED ISSUE IMPACTED CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THERE WERE CRACKS IN THE CARTRIDGE.

    Additional Manufacturer Narrative · 2

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 2

    RECEIVED INFO REGARDING A CARTRIDGE ALARM 1 AND 19 DURING LOAD/BOLUS DELIVERY. THE REPORTED ISSUE IMPACTED CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THERE WERE CRACKS IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267865 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002598

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR
    2 33 YR Other