BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

    MDR report key: 20864455 · Received December 6, 2024

    Report

    Report Number
    1823260-2024-03554
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 9, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    UDI-DI
    04015630921508
    PMA / PMN Number
    K053603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRPHS REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS INTEGRA 400 PLUS ANALYZER SERIAL NUMBER WAS (B)(6). THE QC WAS WITHIN RANGE. THE EXCHANGE OF BOTH PROBES, THE MAINTENANCE OF THE WASH STATIONS, AND THE CLEANING OF THE INTERNAL WATER RESERVOIR WERE LAST PERFORMED IN (B)(6) 2024. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE RESULT OF 1146.2 MG/L WAS ACCOMPANIED BY A DATA FLAG AND TESTED WITH 1:15 DILUTION. THE RESULT OF 1171.5 MG/L WAS ACCOMPANIED BY A DATA FLAG AND TESTED WITH 1:15 DILUTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE PRODUCT MEETS THE SPECIFICATIONS. THE CAUSE OF THE EVENT WAS DUE TO A USER-HANDLING ERROR WHERE THE WRONG ASSAY WAS USED (THE PRIMARY MEASURING RANGE EXCEEDED 5 TIMES). THE CAUSE WAS ALSO CONSISTENT WITH A SAMPLE QUALITY ISSUE AND CUP CONFIGURATION.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE (CRPHS) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. INITIAL RESULT: 1146.2 MG/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT WAS HIGH AND DID NOT CORRESPOND TO THE PATIENT'S CLINICAL PICTURE. THE PHYSICIAN ALSO REQUESTED A REPEAT OF THE SAMPLE. 1ST REPEAT RESULT: 1171.5 MG/L. 2ND REPEAT RESULT: 114.5 MG/L (TESTED WITH 1:15 DILUTION). 3RD REPEAT RESULT: 116.1 MG/L (TESTED WITH 1:15 DILUTION). THE 2ND AND 3RD REPEAT RESULTS CORRESPONDED TO THE PATIENT'S CLINICAL PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486652 CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL NQD ROCHE DIAGNOSTICS 79281601 04015630921508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown