BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIZORB

    MDR report key: 22913325 · Received August 28, 2025

    Report

    Report Number
    MW5175329
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 22, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ALCRESTA THERAPEUTICS, INC.
    Product Code
    PLQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AT AROUND 0200 PATIENT DEXCOM WAS READING DECREASED BLOOD GLUCOSE. REGISTERED NURSE NOTICED THAT THE RELIZORB ATTACHED TO THE ELECARE 30 KILOCALORIES/OUNCE WAS CRACKED OFF THE PATIENT G TUBE (GASTROSTOMY TUBE) EXTENSION. THE ORANGE CONNECTOR PIECE OF THE RELIZORB REMAINED DISLODGED IN THE ATTACHED G TUBE EXTENSION, WHILE THE FEEDS WERE POURING INTO PATIENT BED. PROVIDER WAS NOTIFIED, G TUBE EXTENSION WAS REPLACED. HOWEVER, OTHER REGISTERED NURSES HAVE VOICED THAT THIS IS AN ONGOING ISSUE WITH THIS PATIENT, IN PREVIOUS NIGHTS MULTIPLE RELIZORB CARTRIDGES HAVE CRACKED LEADING TO DECREASED BLOOD GLUCOSE. LOT NUMBER FOR RELIZORB IS 3423910000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164003 RELIZORB ENZYME PACKED CARTRIDGE PLQ ALCRESTA THERAPEUTICS, INC. 3423910000

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male