BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN TINA-QUANT ALBUMIN

    MDR report key: 6184883 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-01984
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 6, 2016
    Report Date
    February 24, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIR
    PMA / PMN Number
    K932950
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATIONS PERFORMED WITH THE AFFECTED PATIENT SAMPLE AND THE SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2016 PRIOR TO THE FLUORESCITE TREATMENT SHOWED LINEARITY UNTIL 800 FOLD DILUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE DETERMINED THAT THE FLUORESCINE DOES NOT HAVE ANY IMPACT ON THE MEASURED RESULTS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT URINE SAMPLE TESTED FOR ALBUMIN TINA-QUANT ALBUMIN (MALB) ON A JCA-BM8040 ANALYZER (MANUFACTURED BY JEOL). THE SAMPLE INITIALLY RESULTED AS 3497.3 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY A PHYSICIAN. THE CUSTOMER ALSO STATED THAT THE RESULT DIFFERED FROM A PREVIOUS SAMPLE TESTED ON (B)(6) 2016. THE VALUE OF THE PREVIOUS SAMPLE COULD NOT BE PROVIDED. THE SAMPLE WAS THEN DILUTED 100 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 3500 MG/DL. THE SAMPLE WAS DILUTED 200 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 1720 MG/DL. THE SAMPLE WAS DILUTED 400 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 1400 MG/DL. THE SAMPLE WAS ALSO DILUTED 800 TIMES AND TESTED, RESULTING WITH A FINAL CALCULATED VALUE OF 640 MG/DL. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835816 ALBUMIN TINA-QUANT ALBUMIN INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) JIR ROCHE DIAGNOSTICS NA 139356

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUORESCITE (FLUORESCEIN)