BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® HIV-1 (192T)

    MDR report key: 23097853 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03207
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    MZF
    UDI-DI
    00875197006407
    PMA / PMN Number
    BP150262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. DATA SETS WERE PROVIDED AND REVIEWED. NO ABNORMAL SHIFTS IN THE CONTROLS OR THE QS OF THE SAMPLE THAT WOULD CAUSE AN UNDER-QUANTIFICATION OR OVER-QUANTIFICATION IN TITER WERE OBSERVED. PRE-ANALYTICS ARE IMPORTANT IN THAT PROPER HANDLING IS NEEDED TO ENSURE THAT THE WHITE BLOOD CELLS ARE NOT DISPERSED INTO THE SAMPLES, SO THAT THE PROVIRAL DNA IS NOT AMPLIFIED. THE ISSUE IS LIKELY RELATED TO THE POTENTIAL ADDITION OF PROVIRAL DNA AMPLIFICATION DURING PREANALYTICAL STEPS.

    Additional Manufacturer Narrative · 0

    THE COBAS 6800 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR SIX PATIENTS. HIV VIRAL LOAD DEVIATIONS ARE OBSERVED IN 6 OUT OF 50 PATIENTS WHO ARE FOLLOWING THERAPY. WHEN TESTED, THE PATIENTS SHOWED HIGHER VIRAL LOADS, WHICH ARE DEEMED INCORRECT DUE TO ADHERENCE TO TREATMENT BY THE PATIENT AND HISTORICAL PATIENT RESULTS. THE FOLLOWING RESULTS WERE OBSERVED: SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 402 CP/ML. REPEAT TEST: ((B)(6)2025) TARGET NOT DETECTED. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 827 CP/ML. REPEAT TEST: ((B)(6)2025) 169 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 131 CP/ML. REPEAT TEST: ((B)(6)2025) <20 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 563 CP/ML. REPEAT TEST: ((B)(6)2025) 82 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 1040 CP/ML. REPEAT TEST: ((B)(6)2025) 1270 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 8510 CP/ML. REPEAT TEST: ((B)(6)2025) 9090 CP/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722324 COBAS® HIV-1 (192T) HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST MZF ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG M08892 00875197006407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown