BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-AMYLASE EPS VER. 2

    MDR report key: 19929735 · Received August 7, 2024

    Report

    Report Number
    1823260-2024-02290
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 22, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    UDI-DI
    07613336121009
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    C503 ANALYZER A SERIAL NUMBER IS (B)(6). THE CUSTOMER'S BACKUP C503 ANALYZER B SERIAL NUMBER WAS NOT PROVIDED. FOR C503 ANALYZER A: NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE REACTION MONITOR DATA. CALIBRATION WAS ACCEPTABLE. QC RESULTS WERE NOT STABLE AND THERE WERE RESULTS OUTSIDE OF THE ACCEPTABLE RANGE. SAMPLE ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. INSTRUMENT CHECKS PASSED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FOR C503 ANALYZER A: NO FURTHER DATA OR INFORMATION CAN BE PROVIDED AS THE INSTRUMENT WAS DAMAGED IN A HURRICANE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR LIPASE COLORIMETRIC ASSAY (LIPC) AND A-AMYLASE EPS VER. 2 (AMYL2) ON 2 COBAS C 503 ANALYTICAL UNITS. THIS MEDWATCH WILL COVER AMYL2. REFER TO MEDWATCH WITH A1: PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LIPC RESULTS. ON (B)(6) 2024 THE INITIAL LIPC RESULT FROM C503 ANALYZER A WAS 292 U/L. THE AMYL2 RESULT WAS 161 U/L. ON (B)(6) 2024 THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY USING A COBAS 6000 C501 MODULE WHERE THE LIPC RESULT WAS 38 U/L AND THE AMYL2 RESULT WAS 86 U/L. THESE RESULTS WERE BELIEVED TO BE CORRECT. ON (B)(6) 2024 THE ORIGINAL SAMPLE WAS REPEATED ON THE CUSTOMER'S BACKUP C503 ANALYZER B AND THE LIPC RESULT WAS 279 U/L AND THE AMYL2 RESULT WAS 164 U/L. ON (B)(6) 2024 A NEW SAMPLE WAS OBTAINED AND RUN ON C503 ANALYZER A WITH A LIPC RESULT OF 102 U/L AND AN AMYL2 RESULT OF 124 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579928 A-AMYLASE EPS VER. 2 AMYLASE TEST SYSTEM JFJ ROCHE DIAGNOSTICS 08056811190 78487101 07613336121009

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male