BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS+

    MDR report key: 2860264 · Received November 9, 2012

    Report

    Report Number
    1217157-2012-00056
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, THE FIELD SERVICE REPRESENTATIVE REPORTED THAT THEY SENT CUSTOMER AN OLD PACKAGE (B)(4) REVISION THAT DID NOT INCLUDE THE CURRENT QUALITY CONTROL RECOMMENDATIONS TO RUN QC EVERY 30 DAYS, NEW LOT, NEW SHIPMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THREE BOTTLES OF URITSTIX LOT 109011 WERE RECEIVED WITH NO INSTRUCTIONS FOR USE. THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE MISSING INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS+ CT STATUS+ KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1