BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY STRIP

    MDR report key: 4863275 · Received June 18, 2015

    Report

    Report Number
    2023446-2015-00178
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER USED A NEW VIAL OF CHEMISTRY STRIPS AND THIS RESOLVED THE ISSUE. THE CUSTOMER WAS SENT A REPLACEMENT LOT OF CHEMISTRY STRIPS. THE ROOT CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED TO DATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED ERRONEOUS PATIENT RESULTS WERE GENERATED ON THE ICHEM VELOCITY INSTRUMENT. THE CUSTOMER INDICATED THERE WERE FALSE NEGATIVE PATIENT RESULTS FOR PROTEIN AND AN UNKNOWN NUMBER OF PATIENT SAMPLES WERE REPORTED OUT OF THE LAB. THERE WERE NO CHANGES TO PATIENT MANAGEMENT AND NO INJURIES REPORTED. THE CUSTOMER ALSO STATED QUALITY CONTROLS WERE NOT PASSING. THE PHYSICIAN QUESTIONED THE PATIENT RESULTS DUE TO THE PATIENT'S CURRENT MEDICAL CONDITION. THE CUSTOMER CONFIRMED CORRECT RESULT BY RECOLLECTING PATIENT SAMPLES AND RE-RUNNING ON ALTERNATE INSTRUMENT. THE CUSTOMER WAS USING CHEMISTRY STRIP LOT 7204081A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398353 ICHEM VELOCITY STRIP URINE CHEMISTRY STRIP KQO IRIS INTERNATIONAL NA 7204081A

    Patients

    Seq Age Sex Outcome Treatment
    1