BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HIV DUO REAGENT PACK

    MDR report key: 16043481 · Received December 22, 2022

    Report

    Report Number
    MW5113985
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    November 16, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LAB SPECIMEN DRAWN FROM PT ON (B)(6) 2022. ELECSYS HIV DUO (AB/AG) PERFORMED ON ROCHE COBAS PRO PRODUCED A REPEATEDLY POSITIVE RESULT ON (B)(6) 2022. RESULT WAS REPORTED TO PROVIDER AND STATE AGENCY (SCDHEC). CONFIRMATORY TESTING ON THE SAME SPECIMEN SENT TO LABCORP FOR 4TH GENERATION HIV AB/AG. CONFIRMATORY TESTING WAS PERFORMED (B)(6) 2022 AND WAS NEGATIVE FOR HIV-1/HIV-2 AB AND NEGATIVE FOR P24 AG INDICATING NO LAB EVIDENCE OF HIV INFECTION. ROCHE COBAS PRO ELECSYS HIV DUO (AHIV AND HIVAG) AND ACCEPTABLE CALIBRATION AND QC FOR DATE OF TESTING. TESTING DISCREPANCY REPORTED TO ROCHE DIAGNOSTICS CASE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653875 ELECSYS HIV DUO REAGENT PACK TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS, INC. 582002
    2653876 ROCHE COBAS PRO CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE MZF ROCHE MOLECULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other