BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UA2

    MDR report key: 17390063 · Received July 25, 2023

    Report

    Report Number
    1823260-2023-02477
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    04015630919154
    PMA / PMN Number
    K922762
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA ON THE DAY OF THE EVENT WAS OK. CONTROLS WERE WITHIN RANGE ON THE DAY OF THE EVENT. A GENERAL REAGENT ISSUE CAN BE RULED OUT AS CALIBRATION AND CONTROLS ARE ACCEPTABLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH A DETERIORATED REAGENT DUE TO STORAGE OR TRANSPORT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH UA2 (URIC ACID) ON A COBAS INTEGRA 400 PLUS SYSTEM. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING REAGENT LOT 693815. THE SECOND MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING A SECOND PACK OF REAGENT LOT 693815. THE THIRD MEASUREMENT OF EACH SAMPLE WAS PERFORMED USING REAGENT LOT NUMBER 714189. SAMPLE 1 URIC ACID RESULTS: MEASUREMENT 1 = 0.76 MG/DL MEASUREMENT 2 = 0.71 MG/DL MEASUREMENT 3 = 6.05 MG/DL SAMPLE 2 URIC ACID RESULTS: MEASUREMENT 1 = 0.86 MG/DL MEASUREMENT 2 = 0.91 MG/DL MEASUREMENT 3 = 7.45 MG/DL SAMPLE 3 URIC ACID RESULTS: MEASUREMENT 1 = 0.46 MG/DL MEASUREMENT 2 = 0.43 MG/DL MEASUREMENT 3 = 3.93 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697193 UA2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS NA 69381501 04015630919154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown