BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ¿-AMYLASE EPS VER.2

    MDR report key: 24660351 · Received March 23, 2026

    Report

    Report Number
    1823260-2026-01024
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    UDI-DI
    04015630924875
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QC WAS ACCEPTABLE. PRE-ANALYTICAL HANDLING ANALYSIS SHOWED NO ABNORMALITIES. THE CUSTOMER HAS CONFIRMED THAT THIS ISSUE IS NOT RELATED TO THE INSTRUMENT, AS THE VERIFICATION RESULTS FOR THIS SAMPLE WERE CONSISTENT ON OTHER INSTRUMENTS. A REVIEW OF THE REACTION MONITOR ANALYSIS SHOWED THAT THE KINETICS OF THE UNDILUTED SAMPLE LOOK LIKE A CLEARING UP OF A TURBIDITY IN SOLUTION. DUE TO THE MULTIPLE MEDICATIONS INVOLVED, THE OBSERVED KINETICS LIKELY STEM FROM A COMBINATION OF UNKNOWN FACTORS, MAKING A DEFINITIVE ROOT CAUSE EXTREMELY DIFFICULT TO PINPOINT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE AMYLASE EPS VER.2 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT. THE INITIAL RESULT WAS -1 U/L (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS 199 U/L WITH A 5-FOLD DILUTION. THE SAMPLE WAS REPEATED NEAT AND THE RESULT WAS 0 (ACCOMPANIED BY A DATA FLAG), AND WITH A 1:5 DILUTION, THE RESULT WAS 198 U/L. NO ERRONEOUS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. AN INTERFERENCE IS SUSPECTED IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199795 ¿-AMYLASE EPS VER.2 SACCHAROGENIC, AMYLASE JFJ ROCHE DIAGNOSTICS 91012401 04015630924875

    Patients

    Seq Age Sex Outcome Treatment
    1