BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN PUMP

    MDR report key: 6109429 · Received November 17, 2016

    Report

    Report Number
    3007981285-2016-20071
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 30, 2016
    Report Date
    October 30, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP"). (PROCODE- CORRECTED TO "LZG").

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DID NOT DETECT THE CARTRIDGE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762529 INSULIN PUMP LZG TANDEM DIABETES CARE

    Patients

    Seq Age Sex Outcome Treatment
    1