BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 16498612 · Received March 7, 2023

    Report

    Report Number
    1823260-2023-00712
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    January 30, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    UDI-DI
    04015630940370
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS COULD BE REPRODUCED. NA.

    Additional Manufacturer Narrative · 0

    THE PATIENT IS HEALTHY AND PARTICIPATES IN A LOT OF SPORTS. THE PATIENT HAD NEGATIVE RESULTS FOR CRP AND RHEUMATOID FACTOR. THE LAST CALIBRATION PERFORMED ON 14-DEC-2022 WAS WITHIN EXPECTATIONS. QUALITY CONTROLS RECOVERED WITHIN SPECIFIED RANGES. FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE DETERMINED THAT IT CONTAINS A POTENTIAL INTERFERING FACTOR AGAINST A COMPONENT OF ONE LOT OF ANTI-CCP REAGENT (LOT 637426), RESULTING IN A FALSE LOW ANTI-CCP VALUE. FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCY WAS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM ONE PATIENT AND TESTED WITH ELECSYS ANTI-CCP ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4) AND A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(4). THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. WHEN THE FIRST SAMPLE WAS TESTED ON THE E 801 ANALYZER, IT RESULTED IN AN ANTI-CCP VALUE OF 41.1 U/ML ON (B)(6) 2023. THIS SAMPLE WAS REPEATED ON THE E 601 ANALYZER ON (B)(6) 2023, RESULTING IN A VALUE OF < 7.00 U/ML WITH A DATA FLAG. THE SECOND SAMPLE HAD SIMILAR RESULTS. ON (B)(6) 2023, THE SECOND SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 38.0 U/ML WHEN TESTED ON THE E 801 ANALYZER. THIS SAMPLE RESULTED IN A VALUE OF < 7.00 U/ML WHEN TESTED ON THE E 601 ANALYZER. ANTI-CCP REAGENT LOT 66022801 (EXPIRATION DATE = 30-SEP-2023) WAS USED ON THE E 801 ANALYZER. ANTI-CCP REAGENT LOT 637426 WAS USED ON THE E 601 ANALYZER. THIS REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716583 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 66022801, 637426 04015630940370

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female