BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMSTRIP 10 UA

    MDR report key: 3523222 · Received December 17, 2013

    Report

    Report Number
    1823260-2013-07702
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    November 7, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K896454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THERE WAS NO CUSTOMER MATERIAL AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE GLUCOSE RESULTS ON THEIR CHEMSTRIP 10 TEST STRIP. THE PATIENT'S GLUCOSE RESULT FROM THE CHEMSTRIP WAS NEGATIVE AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE PATIENT WAS THEN TESTED IN THE LABORATORY AND THE RESULT WAS POSITIVE. THE SPECIFIC LABORATORY RESULT WAS REQUESTED BUT NOT PROVIDED. THIS RESULT WAS THEN REPORTED OUTSIDE THE LABORATORY, AS WELL. IT WAS UNKNOWN IF THE RESULTS CAME FROM THE SAME PATIENT SAMPLE. THERE WERE NO ADVERSE EVENTS. THE PROVIDED CHEMSTRIP 10 LOT NUMBER WAS 1203479; HOWEVER, IT WAS UNKNOWN IF THAT WAS THE CORRECT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659005 CHEMSTRIP 10 UA METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)21 JIL ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1