BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

    MDR report key: 20171306 · Received September 9, 2024

    Report

    Report Number
    1823260-2024-02599
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 19, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    UDI-DI
    07613336120972
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). CALIBRATION AND QUALITY CONTROL DATA WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ALL AFFECTED PATIENTS HAVE MYELOMA WITH HIGH WHITE BLOOD CELL COUNTS. SAMPLES WITH HYPER-LEUKOCYTOSIS MAY SHOW HIGHER ALP ACTIVITY DUE TO THE PRESENCE OF LEUKOCYTES, DEBRIS, AND PLATELETS. A REAGENT ISSUE IS UNLIKELY BECAUSE CALIBRATION AND QC DATA ARE ACCEPTABLE. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 1157 U/L. THE SAMPLE WAS REPEATED FIVE TIMES, RESULTING IN VALUES OF 486 U/L WITH A DATA FLAG, 819 U/L, 410 U/L, 409 U/L, AND 442 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 234 U/L. THE REPEAT VALUE OF 234 U/L WAS BELIEVED TO BE CORRECT. THE SECOND SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 345 U/L. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 522 U/L, 391 U/L, AND 367 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 357 U/L. THE REPEAT VALUE OF 357 U/L WAS BELIEVED TO BE CORRECT. THE THIRD SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 729 U/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 445 U/L AND 439 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 437 U/L. THE REPEAT VALUE OF 437 U/L WAS BELIEVED TO BE CORRECT. THE FOURTH SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 206 U/L ON (B)(6) 2024. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 113 U/L AND 91 U/L. THE SAMPLE WAS RE-CENTRIFUGED AND PLACED IN A SAMPLE CUP THEN REPEATED, RESULTING IN A VALUE OF 83 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538552 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS 807290 07613336120972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown