BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMYL2 ALPHA-AMYLASE EPS VER.2

    MDR report key: 5004597 · Received August 14, 2015

    Report

    Report Number
    1823260-2015-03968
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    August 1, 2014
    Report Date
    August 14, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIJ
    PMA / PMN Number
    K882225
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, THE CUSTOMER STATED THAT THEY TESTED A NEW SAMPLE FROM THE SAME PATIENT FOR AMYL2 ON A C701 ANALYZER. THIS SAMPLE RESULTED WITH AN AMYL2 VALUE OF 585 U/L AND THE GENERAL PRACTITIONER WAS AWARE OF THIS RESULT. THE RESULT WAS SAID TO BE IMPLAUSIBLY HIGH. LAST YEAR, THE PATIENT WAS SENT TO THE HOSPITAL WHERE THEY FOUND ONLY PHYSIOLOGICAL AMYL2 VALUES, BUT THE PATIENT DID NOT SHOW ANY SIGNS OF PANCREATITIS OR ILLNESS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE C701 ANALYZER SERIAL NUMBER WAS (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE HIGH AMYL2 RESULT OBTAINED BY THE CUSTOMER COULD BE REPRODUCED AND IS CONSIDERED TO BE CORRECT. NO TURBIDITY WAS FOUND IN THE PATIENT SAMPLE, MEANING THAT THERE IS NO UNSPECIFIC INTERFERENCE CAUSED BY PRECIPITATION. THE LIPASE VALUE OF THE SAMPLE WAS FOUND TO BE NORMAL, INDICATING NO INFLAMMATION OF PANCREATIC CELLS. GAMMOPATHY COULD ALSO BE EXCLUDED IN THE SAMPLE. ALL DRUGS THE PATIENT WAS TAKING ARE LOW DOSE DRUGS, SO IT IS HIGHLY IMPROBABLE THAT A DRUG INTERFERENCE IS THE ROOT CAUSE OF THE ISSUE. THE MOST LIKELY ROOT CAUSE FOR THE HIGH AMYL2 RESULT IS ASSUMED TO BE MEASUREMENT OF MACRO-AMYLASE.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR A- AMYLASE EPS VER.2 (AMYL2). ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE TREATING PHYSICIAN INDICATED THAT THIS PATIENT UNDERGOES ROUTINE BLOOD TESTS REGULARLY. IN AUGUST 2014 THE INITIAL AMYL2 RESULT WAS 681 U/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY WAS 36 U/L. ON (B)(6) 2015 THE INITIAL AMYL2 RESULT WAS 656 U/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY WAS 42 U/L. ON (B)(6) 2015 THE INITIAL AMYL2 RESULT WAS 568 U/L AND THE PATIENT WAS SENT TO THE HOSPITAL. THE PATIENT WAS TESTED AT THE HOSPITAL WITH AN AMYLASE RESULT OF APPROXIMATELY 50 U/L AND RELEASED. THE (B)(6) 2015 SAMPLE WAS REPEATED IN THE CUSTOMER'S LABORATORY WITH AN AMYL2 RESULT OF 560 U/L. NO ADVERSE EVENT OCCURRED. THE PATIENT IS IN GOOD CONDITION. THE AMYL2 REAGENT LOT WAS 611180 WITH AN EXPIRATION DATE OF 02/2016. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A REAGENT ISSUE CAN BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538544 AMYL2 ALPHA-AMYLASE EPS VER.2 SACCHAROGENIC, AMYLASE CIJ ROCHE DIAGNOSTICS NA 138936

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR