BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS

    MDR report key: 2818468 · Received October 23, 2012

    Report

    Report Number
    1217157-2012-00047
    Event Type
    Other
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    CEM
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ADVISED TO STOP USING MULTISTIX AND INSTRUMENT UNTIL THE SYSTEM WAS CHECKED. MFR SERVICE ENGINEER CHECKED THE INSTRUMENT AND REPORTED RESULTS WERE IN RANGE WHEN QC WAS PERFORMED ON THE INSTRUMENT. WE HAVE NO PT SAMPLE TO EVALUATE. THE CUSTOMER WAS EXPERIENCING THE ISSUE WITH ONLY ONE SPECIFIC PT, WHICH WOULD INDICATE THAT THERE IS A POSSIBILITY OF AN INTERFERENT PRESENT AND WITHOUT THE SAMPLES WE WILL NOT BE ABLE TO DETERMINE THE EXACT INTERFERENT. A REAGENT ISSUE IS NOT SUSPECTED, SINCE THEY ARE NOT REPORTING ANY ISSUES WITH OTHER PTS AND THEIR QC TESTING IS FINE. AS A RESULT, IT IS NOT NECESSARY TO TEST THE REAGENT STRIPS ALONE. THIS IS THE ONLY COMPLAINT RECEIVED FOR REAGENT LOT 111078 (MANUFACTURED NOVEMBER 2011). THE NITRITE TEST WAS POSITIVE, WHICH WOULD INDICATE THE PRESENCE OF SIGNIFICANT NUMBER OF BACTERIA WHEN USED WITH OTHER SIGNS AND SYMPTOMS WOULD INDICATE A UTI. ALSO, AS PER THE IFU, "AS WITH ALL LAB TESTS, DEFINITIVE DIAGNOSIS OR THERAPEUTIC DECISIONS SHOULD NOT BE BASED ON ANY SINGLE RESULT OR METHOD."

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE RESULT FOR LEUKOCYTES WHEN USING MULTISTIX 7 URINE STRIP. THE SAME SAMPLE WAS 2+ FOR LEUKOCYTES WHEN MEASURED USING COMBUR STRIP. DELAY IN PT TREATMENT REPORTED DUE TO FALSE NEGATIVE RESULT. NO REPORT OF INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS CT STATUS+ CEM SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1