BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AFP

    MDR report key: 22148851 · Received June 5, 2025

    Report

    Report Number
    1823260-2025-01725
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOJ
    UDI-DI
    04015630939909
    PMA / PMN Number
    K981282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE SAMPLE SHOWED NO HEMOLYSIS OR LIPID. THE CUSTOMER PERFORMED POLYETHYLENE GLYCOL (PEG) 6000 PRECIPITATION EXPERIMENT, AND THE RECOVERY RATE WAS NORMAL WITH NO ABNORMAL FLUCTUATIONS. THE AFP RESULTS WERE AS FOLLOWS: 98.0 NG/ML WITH NO DILUTION. 98.5 NG/ML WITH A DILUTION FACTOR OF 1:2. 97.9 NG/ML WITH A DILUTION FACTOR OF 1:5. 96.3 NG/ML WITH A DILUTION FACTOR OF 1:10. 53.5 NG/ML OBTAINED TWICE. THE CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED FOR INVESTIGATION, WHERE IT WAS MEASURED ON A COBAS E801, OBTAINING A RESULT OF 82.2 IU/ML (99.462 NG/ML), CONFIRMING THE ELECSYS RESULT GENERATED BY THE CUSTOMER. ON (B)(6) 2025, THE SAMPLE WAS TESTED USING A COMPETITOR METHOD (SNIBE) AT AN EXTERNAL LABORATORY, RESULTING IN THE FOLLOWING: 1ST MEASUREMENT: 87.4 IU/ML. 2ND MEASUREMENT: 86.3 IU/ML. SNIBE REFERENCE RANGE: = 6.05 IU/ML. THE SNIBE RESULTS WERE CONSISTENT WITH THE ELECSYS RESULTS. NO INTERFERENCE WAS IDENTIFIED DURING PEG PRECIPITATION EXPERIMENTS AT THE CUSTOMER SITE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SAMPLE WHEN TESTED WITH ELECSYS ALPHA 1-FETOPROTEIN (AFP) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 91.3 NG/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND REPEATED THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. AFP RESULT ON WAKO CHEMILUMINESCENCE: 2.7 NG/ML, AND THIS RESULT WAS CONSIDERED NORMAL (REFERENCE RANGE: 0-7 NG/ML). AFP-L3/AFP: <0.5 % (REFERENCE RANGE: 0-9.99). PIVKA RESULT ON FUJI CHEMILUMINESCENCE ANALYZER (FUJIREBIO LUMIPULSE G1200): 22 MAU/ML (REFERENCE RANGE: 0-40 MAU/ML). THE PATIENT'S MAGNETIC RESONANCE IMAGING (MRI) EXAMINATION SHOWED NO ABNORMALITY. THE CUSTOMER BELIEVED THAT THE WAKO RESULT WAS CORRECT. THE CUSTOMER SUSPECTED AN INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936819 ELECSYS AFP KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER LOJ ROCHE DIAGNOSTICS 80176901 04015630939909

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female