BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM 100

    MDR report key: 3748618 · Received November 22, 2013

    Report

    Report Number
    2023446-2013-00012
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    August 15, 2013
    Report Date
    November 22, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JJW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IRIS PRODUCT IFU INSERT STATES THAT THE DIAGNOSTIC OR THERAPEUTIC DECISIONS SHOULD NOT BE BASED ON ANY SINGLE RESULT OR METHOD. THEREFORE DECISION OF CLINICIAN TO ADMINISTER THERAPY BASED ON SINGLE FALSE POSITIVE OR FALSE NEGATIVE RESULT IS INDICATIVE OF USES OF DEVICE OFF LABELED CLAIM. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT: 2023446-2013-00001, 2023446-2013-0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013.

    Description of Event or Problem · 1

    FALSE POSITIVE LEUKOCYTE ESTERASE WAS REPORTED ON 101 PT RESULTS WHICH LEAD TO 12 PTS TO RECEIVE UNNECESSARY ANTIBIOTICS. THE MALFUNCTION WAS CONFIRMED BY URINE MICROSCOPY AND URINE CULTURES WHICH WERE NEGATIVE FOR URINARY TRACT INFECTION IN ALL 12 PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610219 ICHEM 100 URINE CHEMISTY STRIPS JJW IRIS INTERNATIONAL 800-7005 510034A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other