BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATININE JAFFE GEN.2

    MDR report key: 20831414 · Received December 3, 2024

    Report

    Report Number
    1823260-2024-03499
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 8, 2024
    Report Date
    February 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGX
    UDI-DI
    07613336121177
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE'S ICTERUS INDEX FROM THE COBAS INTEGRA 400 PLUS WAS 314 (SIGNIFICANTLY ABOVE THE LIMIT). THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH AN ICTERIC PATIENT SAMPLE. PRODUCT LABELING STATES: "LIMITATIONS ¿ INTERFERENCE SERUM/PLASMA ICTERUS (CREJ2) - NO SIGNIFICANT INTERFERENCE UP TO AN I INDEX OF 5 FOR CONJUGATED BILIRUBIN AND 10 FOR UNCONJUGATED BILIRUBIN (APPROXIMATE CONJUGATED BILIRUBIN CONCENTRATION: 86 MOL/L OR 5 MG/DL; APPROXIMATE UNCONJUGATED BILIRUBIN CONCENTRATION: 171 MOL/L OR 10 MG/DL." BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S C 303 ANALYZER IS 2115-03. THE SERIAL NUMBERS OF ALL OTHER ANALYZERS WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS PURE C 303 ANALYTICAL UNIT AND COBAS INTEGRA 400 PLUS ANALYZERS. THE SECOND AND THIRD SAMPLES WERE ALSO TESTED ON A C303 ANALYZER, A COBAS C 311 ANALYZER, AND TWO ADDITIONAL INTEGRA 400 PLUS ANALYZERS AT OTHER SITES. THE FIRST SAMPLE RESULTED IN A CREATININE VALUE OF 102 UMOL/L WHEN TESTED ON THE CUSTOMER'S C 303 ANALYZER. THE SAMPLE WAS REPEATED ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER, RESULTING IN A VALUE OF 39 UMOL/L. THE SECOND SAMPLE RESULTED IN THE FOLLOWING CREATININE VALUES: ON THE CUSTOMER'S C 303 ANALYZER = 109 UMOL/L AND 108 UMOL/L ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER = 42 UMOL/L AND 45 UMOL/L ON A SECOND C303 SYSTEM AT A SECOND SITE = 105 UMOL/L ON A C311 ANALYZER AT A SECOND SITE = 84 UMOL/L AND 90 UMOL/L WITH A DATA FLAG ON A SECOND INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 51 UMOL/L ON A THIRD INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 46 UMOL/L THE THIRD SAMPLE RESULTED IN THE FOLLOWING CREATININE VALUES: ON THE CUSTOMER'S C 303 ANALYZER = 120 UMOL/L ON THE CUSTOMER'S INTEGRA 400 PLUS ANALYZER = 52 UMOL/L AT THE CUSTOMER SITE USING A RAPID TEST STRIP METHOD (STAT SENSOR EXPRESS) = 110 UMOL/L ON A SECOND C303 SYSTEM AT A SECOND SITE = 108 UMOL/L ON A C311 ANALYZER AT A SECOND SITE = 93 UMOL/L ON A SECOND INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 48 UMOL/L ON A THIRD INTEGRA 400 PLUS ANALYZER AT A THIRD SITE = 47 UMOL/L

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245697 CREATININE JAFFE GEN.2 CREATININE, ALKALINE PICRATE COLORIMETRY CGX ROCHE DIAGNOSTICS 759219 07613336121177

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Unknown