BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO BIOGRAPH

    MDR report key: 2543331 · Received April 13, 2012

    Report

    Report Number
    3003288808-2012-00144
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 16, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    HJO
    PMA / PMN Number
    K082891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE AXIAL LENGTH MEASURE VALUE DIFFERED FROM THE CALCULATION VALUE. THE SYSTEM WAS REPORTED TO HAVE USED THE CALCULATED VALUE INSTEAD OF THE MEASURED VALUE AS PREFERRED BY THE USER. WHEN THE MEASURE VALUE WAS LATER CHECKED BY A SERVICE ENGINEER, AN ERROR WAS RECEIVED. NO PT HARM/INJURY WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO BIOGRAPH OPTICAL LOW COHERENCE REFLECTOMETRY (O:LCR) BIOMETER HJO WAVELIGHT GMBH 8065990672 NA

    Patients

    Seq Age Sex Outcome Treatment
    1