BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANMATE A

    MDR report key: 6190143 · Received December 20, 2016

    Report

    Report Number
    2522950-2016-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    November 26, 2016
    Manufacturer
    DGH TECHNOLOGY, INC.
    Product Code
    ITX
    UDI-DI
    00857377006094
    PMA / PMN Number
    K093371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 12/20/2016, THE DEVICE HAS BEEN RETURNED TO THE DISTRIBUTOR ((B)(4)). (B)(4) IS TO COORDINATE RETURNING THE DEVICE TO DGH.

    Description of Event or Problem · 1

    A USER (DR. (B)(6)) ALLEGED EXPERIENCING MEASUREMENT ERRORS WHEN USING A DGH 6000 A-SCAN DEVICE. THE DOCTOR STATED THAT WHEN PERFORMING CONTACT AXIAL LENGTH MEASUREMENTS OF THE EYE, (IN APPROXIMATELY 2 OF EVERY 10 CASES) HE WOULD HAVE DIFFICULTY OBTAINING MEASUREMENTS. HE SAID IN THESE INSTANCES THE DEVICE WOULD ENTER ESTIMATE MODE AND MEASUREMENTS TAKEN WHILE IN ESTIMATE MODE DIFFERED FROM AXIAL LENGTH MEASUREMENTS ACHIEVED WITH HIS PREVIOUS A-SCAN DEVICE. THIS DIFFERENCE IN MEASUREMENT WOULD RESULT IN A REFRACTIVE CALCULATION ERROR OF 2-3 DIOPTERS. THE DOCTOR CLAIMED THAT INSTANCES OF DIFFICULTY WERE TYPICALLY EXPERIENCED WHEN ATTEMPTING TO MEASURE EYES WITH A MATURE CATARACTS OR POSTERIOR SUB CAPSULAR CATARACT (PSC). HE STATED THAT IN OTHER CASES (WHEN NOT MEASURING MATURE CATARACTS OR POSTERIOR SUB CAPSULAR CATARACT), THE READINGS ARE SATISFACTORY AND ACCURATE. MEASUREMENT INFORMATION FOR ONE PATIENT ((B)(6)) WAS PROVIDED, WHOSE MEASUREMENTS DIFFERED BY 0.75 MM WHEN COMPARED TO THE PREVIOUS DEVICE. THE DOCTOR HAS STATED THAT NO INJURIES HAVE OCCURED AS A RESULT OF THE MEASUREMENT DIFFERENCE. IN CASES WHERE MEASUREMENTS OBTAINED WITH THE DGH 6000 DIFFERED FROM HIS PREVIOUS DEVICE, MEASUREMENTS ACHIEVED WITH THE PREVIOUS DEVICE WERE USED FOR REFRACTIVE CALCULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840366 SCANMATE A ULTRASONIC A-SCAN ITX DGH TECHNOLOGY, INC. DGH 6000 00857377006094

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR