BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ¿-CROSSLAPS/SERUM IMMUNOASSAY

    MDR report key: 12120871 · Received July 6, 2021

    Report

    Report Number
    1823260-2021-01920
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    May 18, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    PMA / PMN Number
    K993706
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FROM THE ANALYSIS OF THE CALIBRATION SIGNALS AND CONTROL VALUES, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) #(B)(4).

    Description of Event or Problem · 1

    THERE WAS AN ALLEGATION OF QUESTIONABLE B-CROSSLAPS/SERUM ELECSYS RESULTS FOR PATIENTS THAT DID NOT MATCH THE CLINICAL PICTURE WITH THE TOTAL P1NP ELECSYS RESULTS. DATA WAS PROVIDED FOR THREE PATIENTS. PATIENT (B)(6): B-CROSSLAPS RESULT WAS 0.604 NG/ML AND P1NP RESULT WAS 33.99 NG/ML. PATIENT (B)(6): ON (B)(6) 2020: B-CROSSLAPS RESULT WAS 0.528 NG/ML AND P1NP RESULT WAS 25.560 NG/ML. PATIENT (B)(6): AFTER TREATMENT, THE P1NP RESULT SHOWED A DECREASE AND THE B-CROSSLAPS RESULT STAYED ALMOST THE SAME. ON (B)(6) 2015, THE B-CROSSLAPS RESULT WAS 0.875 NG/ML AND P1NP RESULT WAS 59.30 NG/ML. ON (B)(6) 2021: B-CROSSLAPS RESULT WAS 0.510 NG/ML AND P1NP RESULT WAS 28.350 NG/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER USED COBAS E411 DISK ANALYZER SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022081 ELECSYS ¿-CROSSLAPS/SERUM IMMUNOASSAY COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE JMM ROCHE DIAGNOSTICS NA 511263

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown