BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 405

    MDR report key: 4111355 · Received September 23, 2014

    Report

    Report Number
    1217157-2014-00133
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GKR
    PMA / PMN Number
    K020616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT RESULTS CROSSED TO DATA MANAGEMENT SYSTEM (RAPIDCOMM) AND THEY INVALIDATED THE RESULTS AND RESULTS WERE NOT REPORTED OUT. CUSTOMER INDICATED THAT THERE WAS NO ISSUE WITH THE INSTRUMENT AND OPERATOR SCANNED THE WRONG BAR CODE LABEL. CUSTOMER CONFIRMED THAT IT WAS AN OPERATOR ERROR AND THEY DO NOT WANT TO PURSUE THE MATTER ANY FURTHER. INSTRUMENT IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSTRUMENT READ BARCODE INCORRECTLY AS 5439377 WHEN THEY RAN SAMPLE WITH BARCODE# 5437421. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589878 RAPIDPOINT 405 RP 405 GKR SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1