BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP ® 10 MD

    MDR report key: 12860228 · Received November 23, 2021

    Report

    Report Number
    1823260-2021-03450
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LJX
    UDI-DI
    00075537313121
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QCS MEET ACCEPTANCE CRITERIA. THERE HAVE BEEN NO FURTHER ISSUES REPORTED. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. NO MATERIAL WAS RECEIVED. THE RETENTION MATERIAL MEASUREMENTS FULFILL THE REQUIREMENTS AND MEET ALL SPECIFICATIONS. NO FALSE-NEGATIVE LEUKOCYTE RESULTS WERE OBTAINED. THE EVENT IS CONSISTENT WITH A SAMPLE THAT IS NOT STORED CORRECTLY OR MEASURED WITHIN TWO HOURS, DUE TO CELL LYSE FALSIFYING THE MICROSCOPY RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS A COMPLAINT OF A QUESTIONABLE LEUKOCYTE RESULT FOR 1 PATIENT TESTED WITH A URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S INITIAL METER RESULT WAS NEGATIVE. THE CUSTOMER LOOKED AT THE SAMPLE UNDER THE MICROSCOPE AND SAW APPROXIMATELY 20 - 30 WHITE CELLS. THE CUSTOMER RERAN THE SAME SAMPLE, SAME STRIP VIAL ON THE METER, AND GOT A RESULT OF 2+ OR 500 LEU/UL. THE TIMING BETWEEN TESTS WAS WITHIN 15 MINUTES. THE SAMPLE TYPE WAS URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757052 CHEMSTRIP ® 10 MD URINE TEST STRIPS LJX ROCHE DIAGNOSTICS NA 54510809 00075537313121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown