BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATUS CS

    MDR report key: 5212191 · Received November 9, 2015

    Report

    Report Number
    1217157-2015-00157
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 16, 2015
    Report Date
    November 13, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    DAP
    PMA / PMN Number
    K051650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): PREMARKET IDENTIFICATION: PMA/510(K): K063356.

    Additional Manufacturer Narrative · 1

    PMA 510(K): PREMARKET IDENTIFICATION: PMA/510(K): K110303.

    Additional Manufacturer Narrative · 1

    EVEN THOUGH SIEMENS MADE AWARE OF THIS COMPLAINT ON (B)(4) 2015; BASED ON THE INVESTIGATION AND ADDITIONAL INFORMATION RECEIVED, SIEMENS MEDICAL AFFAIRS IDENTIFIED THIS ISSUE AS LOW HEALTH RISK (LHR) ON (B)(4) 2015. AS PER PROCEDURE, SIEMENS DID RETROSPECTIVE REVIEW OF ALL ASSOCIATED COMPLAINTS WITH THIS ISSUE AND IDENTIFIED THOSE WITH POTENTIAL SAFETY ISSUES FOR WHICH MEDICAL DEVICE REPORTS NEED TO BE FILED. SIEMENS IS REVISING THE AFFECTED ACUTE CARE TESTPAK, CALPAK, AND DILPAK LABELING TO RESOLVE THIS ISSUE. SIEMENS IS PLANNING TO ISSUE AN URGENT FIELD SAFETY NOTICE TO NOTIFY AFFECTED SIEMENS CUSTOMERS ABOUT THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY GOT MESSAGES ABOUT 'INSUFFICIENT PAKS' AND 'CAN NOT READ THE BARCODES' WHEN THEY TRIED TO CALIBRATE D-DIMER TEST PACKS. CUSTOMER INDICATED THAT THEY TRIED TO CALIBRATE AGAIN AND GOT THE SAME MESSAGES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742076 STRATUS CS STRATUS CS DAP SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1