BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP 10 MD

    MDR report key: 2101030 · Received May 24, 2011

    Report

    Report Number
    1823260-2011-02763
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K032437
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE URISYS 1100 ANALYZER AND STRIPS WERE RETURNED FOR INVESTIGATION. DURING THE INVESTIGATION, THE ANALYZER SHOWED AN ERROR MESSAGE INDICATING AN OPTICAL DEFECT. FURTHER INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE BECAUSE THE LIGHT EMITTING DIODES (LED) OF THE CUSTOMER'S DEVICE WERE DEFECTIVE. THE DEFECTIVE LEDS WERE NOT THE CAUSE OF THE FALSE RESULTS. IF THE LED IS BECOMING WEAK, CALIBRATION WILL COMPENSATE FOR THIS. THE LOT INFORMATION OF THE TEST STRIPS INVOLVED WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE NO INVESTIGATION WITH RETENTION MATERIAL WAS POSSIBLE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER AT THIS TIME. NO PRODUCT RETURNED. LOT NUMBER UNKNOWN.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE URINALYSIS RESULTS FOR ONE PATIENT SAMPLE FROM THE URISYS 1100 ANALYZER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR GLUCOSE WERE DISCREPANT. THE INITIAL RESULT WAS "NORMAL" AND THE RESULT FROM THE IRIS ANALYZER IN THE LABORATORY WAS >1000 MG/DL. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE USER STATED SHE FEELS THE WRONG PATIENT SAMPLE MAY HAVE BEEN SENT TO THE LABORATORY, BUT STATED THE SAMPLE WAS LABELED CORRECTLY. THERE WAS NOT A WAY FOR THE USER CONFIRM IF THE SAMPLE TESTED WAS THE CORRECT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP 10 MD URINE TEST STRIPS JIL ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR