BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ¿-CROSSLAPS/SERUM

    MDR report key: 17129878 · Received June 14, 2023

    Report

    Report Number
    1823260-2023-01962
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 11, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMM
    UDI-DI
    07613336171561
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BUBBLES AND FOAM WERE OBSERVED IN THE PATIENT SAMPLES. THE CUSTOMER HAS SINCE IMPLEMENTED A NEW CENTRIFUGATION STEP AFTER DEFROSTING PATIENT SAMPLES. FOAM ON SAMPLES MAY LEAD TO LOW RESULTS FOR THIS ASSAY. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. NO PRODUCT PROBLEM WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). CALIBRATION WAS LAST PERFORMED ON (B)(6) 2023 WITH ACCEPTABLE RESULTS. QC DATA WAS ACCEPTABLE. MULTIPLE SAMPLE ALARMS WERE OBSERVED DURING A REVIEW OF THE CUSTOMER'S ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON (B)(6) 2023 AND CHECKED MULTIPLE PARTS OF THE INSTRUMENT. THE FSE ADJUSTED THE SAMPLE PROBE ALIGNMENT. THE FSE NOTED MILKY GROWTH IN THE SYRINGES. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS -CROSSLAPS/SERUM IMMUNOASSAY RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES. ON (B)(6) 2023, PATIENT 1 HAD AN INITIAL -CROSSLAPS RESULT OF 70.4 PG/ML. THE REPEAT RESULT WAS 521 PG/ML. ON (B)(6) 2023, PATIENT 2 HAD AN INITIAL -CROSSLAPS RESULT OF 63.3 PG/ML. THE REPEAT RESULT WAS 529 PG/ML. ON (B)(6) 2023, PATIENT 3 HAD AN INITIAL -CROSSLAPS RESULT OF 60.6 PG/ML. THE REPEAT RESULT WAS 548 PG/ML. ON (B)(6) 2023, PATIENT 4 HAD AN INITIAL -CROSSLAPS RESULT OF 60.1 PG/ML. THE REPEAT RESULT WAS 624 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972526 ELECSYS ¿-CROSSLAPS/SERUM COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE JMM ROCHE DIAGNOSTICS NA 64789101 07613336171561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown