BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA URIC ACID 2

    MDR report key: 11057958 · Received December 22, 2020

    Report

    Report Number
    1823260-2020-03330
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    October 14, 2020
    Report Date
    March 1, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    PMA / PMN Number
    K922762
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UNIQUE IDENTIFIER (UDI) # (B)(4). THE LAST CALIBRATION WAS DONE ON 21-SEP-2020 AND WAS ACCEPTABLE. THE QC RECOVERY WAS ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT BUT WAS UNABLE TO DETERMINE ROOT CAUSE OF THE ISSUE. THERE IS NO INDICATION FOR A PERFORMANCE ISSUE OF REAGENT OR INSTRUMENT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE PATIENTS MAY BE RECEIVING THE MEDICATION KRYSTEXXA, BUT THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION REGARDING IF THE PATIENTS WERE TAKING THE PLACEBO OR NOT. THE PATIENT SAMPLES COULD NOT BE PROVIDED FOR INVESTIGATION. BASED ON THE LACK OF DATA PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE URIC ACID RESULTS FOR 7 PATIENT SAMPLES FROM 2 PATIENTS ON A COBAS INTEGRA 400 PLUS MODULE. THE REPEATED RESULTS WERE TESTED ON A DIFFERENT ANALYZER IN A CENTRAL LAB UNLESS STATED OTHERWISE. SAMPLES FROM PATIENT 1 (ID: 204): THE INITIAL RESULT WAS 0.9 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 2.4 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 4.0 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. SAMPLE D: ON (B)(6) 2020 THE INITIAL RESULT WAS 5.1 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. THIS SAMPLE WAS SENT OUT TO LABCORP AND THE RESULT WAS ALSO <0.2 MG/DL. SAMPLES FROM PATIENT 2 (ID: (B)(6)): THE INITIAL RESULT WAS 1.4 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 4.1 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 2.7 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. THE REAGENT LOT NUMBER IS 46051301 WITH AN EXPIRATION DATE OF 28-FEB-2021. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BOTH PATIENTS ARE INVOLVED IN A STUDY FOR MEDICATION WHICH LOWERS URIC ACID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519742 COBAS INTEGRA URIC ACID 2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS I400+ 46051301

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR PATIENT 1: HEADACHE POWDER.| PATIENT 1: INDOMETHACIN.| PATIENT 1: MUCINEX DM.| PATIENT 2: ALENDRONATE SODIUM.| PATIENT 2: AMLODIPINE.| PATIENT 2: ASPIRIN.| PATIENT 2: CARBONYL IRON.| PATIENT 2: CIPROFLAXIN FLAGYL.| PATIENT 2: CIPROFLAXIN FLAGYL.| PATIENT 2: COLCRYS.| PATIENT 2: COLCRYS.| PATIENT 2: FAMOTIDINE.| PATIENT 2: LASIX.| PATIENT 2: PLAVIX.| PATIENT 2: TOPROL XL.| PATIENT 2:HIGH DOSE FLU VACCINE.| PATIENT 2:LIPITOR.| PATIENT 2:METRONIDAZOLE.| PATIENT 2:METRONIDAZOLE.