BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDCOM

    MDR report key: 3329694 · Received August 26, 2013

    Report

    Report Number
    1217157-2013-00158
    Event Type
    Other
    Date Received
    August 26, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE REPORTING OF THE SAME PATIENT NAME WHEN THE PATIENT ID IS INDICATED AS "UNK" IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SAMPLES WITH A PATIENT ID AS "UNKNOWN" ALL HAVE THE SAME NAME. THIS HAS BEEN OCCURRING (B)(6) 2013 (CUSTOMER NOTED 8 EXAMPLES IN THE COMPLAINT). CUSTOMER ALSO INDICATED THAT THERE WERE 133 PATIENTS WITH THIS NAME IN THE PORTAL. THERE WAS NO REPORT OF PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416125 RAPIDCOM RAPIDCOM JQP SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1