BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM LEVEL SENSOR ASSEMBLY

    MDR report key: 24519780 · Received March 5, 2026

    Report

    Report Number
    3006073153-2026-00048
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 5, 2026
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434420893
    PMA / PMN Number
    K173591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONFIRMED THE REPORTED FAULT. THE SENSOR WOULD NOT FUNCTION WHEN CONNECTING TO QWS. THE SENSOR WAS INVENTORY DISPOSED DUE TO POSSIBLE LIQUID INGRESS CAUSING IT TO MALFUNCTION. LIQUID INGRESS IS MOST LIKELY UNINTENTIONAL EXPOSURE OF THE DEVICE OUTSIDE OF ITS INSTRUCTED USE.

    Description of Event or Problem · 0

    USER REPORTED FALSE LEVEL ALARM FROM LEVEL SENSOR, WHICH CAN CAUSE THE PUMP TO UNNECESSARILY STOP OR SLOW. THERE WAS NO PATIENT HARM; HOWEVER, THIS TYPE OF EVENT IS CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581737 QUANTUM LEVEL SENSOR ASSEMBLY LEVEL SENSOR DRY SPECTRUM MEDICAL LTD QLV1 QLV1000269 05060434420893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown