BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDWAYS QCT PRO

    MDR report key: 3760799 · Received April 8, 2014

    Report

    Report Number
    2939827-2014-00001
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2012
    Report Date
    April 8, 2014
    Manufacturer
    MINDWAYS SOFTWARE, INC.
    Product Code
    KGI
    PMA / PMN Number
    K894854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACT THAT THE EVENT (OSTEOPOROTIC FRACTURE) OCCURRED IS CONSISTENT WITH THE RESULTS DELIVERED BY THE DEVICE'S ANALYSIS REPORT. AN APPROPRIATE USE OF THE RESULTS FOLLOWING EXISTING GUIDELINES WOULD HAVE REVEALED THE EXISTING RISK OF THE PT TO FRACTURE. THERE IS NO EVIDENCE FOR A DEVICE RELATED PROBLEM. THERE IS NO EVIDENCE FOR A CAUSAL RELATIONSHIP OF THE ANALYSIS AND THE REPORTED EVENT. HENCE, (B)(4), DERIVES THAT THIS EVENT WAS NOT TO BE REPORTED. INSPECTOR (B)(4) FROM THE US FDA REQUESTED A REPORT.

    Description of Event or Problem · 1

    (B)(6), CLINICAL EDUCATION SPECIALIST AT GE HEALTHCARE, REPORTED ON (B)(6) 2012, THAT A PHYSICIAN PERFORMED A BONE DENSITOMETRY ON HIS SISTER AND ANALYZED THE SCAN USING MINDWAYS QCT PRO, RESULTING IN FOUR VERTEBRAL DENSITIES (UNIT MG/CCM) OF 69.7 (L1), 74.2 (L2), 73.0 (L3), 178.3 (L4). THE ANALYSIS REPORT SHOWED A MEAN DENSITY OF 98.8 MG/CCM. THE REPORT'S FRACTURE RISK GRAPH SHOWED A FRACTURE RISK OF 37%, A Z-SCORE OF 0.05 AND A T-SCORE OF -2.68. THE PHYSICIAN DID NOT DIAGNOSE OSTEOPOROSIS AND ARGUED, THAT UPON HIS OPINION THE Z-SCORE WAS NOT CONSISTENT WITH OSTEOPOROSIS. THE PT WAS REPORTED TO SUFFER AN OSTEOPOROTIC FRACTURE LATER ON. THE PHYSICIAN EXPRESSED HIS MISTRUST OF THE RESULTS OF THE ANALYSIS SOFTWARE MINDWAYS QCT PRO IN GENERAL. IMAGE DATA OF THE PT WAS REQUESTED BY MINDWAYS BUT WAS NOT AVAILABLE AT THE TIME OF INVESTIGATION (IMAGES DELETED FROM SYSTEM AT PHYSICIAN'S SITE). THE RESULT OF VERTEBRA L4 IS 2.4 TIMES LARGER THAN THE HIGHEST OF THE THREE OTHER RESULTS, ALL BEING BELOW 80MG/CCM. IN THE ABSENCE OF FURTHER INFO, ONE OF THE FOLLOWING REASONS COULD EXPLAIN THIS SITUATION: MISAPPLICATION OF THE SOFTWARE, OR A DISEASE BEING ABLE TO IMPACT SINGLE VERTEBRAE LIKE PAGET'S DISEASE. MISUSE: INAPPROPRIATE REGIONS OF INTEREST COULD EXPLAIN THE ABNORMAL VALUE OF L4 IN THE CONTEXT OF THE OTHER VALUES, INCLUDING A HYPOTHETICAL MEASUREMENT OF AN ALREADY FRACTURED VERTEBRA SHOWING HIGHER DENSITY DUE TO COMPRESSION. IT IS PART OF THE DIAGNOSE OF THE PHYSICIAN TO DETECT SUCH A DISEASE. INDEPENDENT OF THE POSSIBILITIES LISTED ABOVE, THE MEAN VALUE OF THE THREE CONSISTENT VERTEBRAE L1, L2 AND L3 IS 72.3 MG/CCM, THE FRACTURE RISK GRAPH CONFIRMS A SIGNIFICANT RISK OF 57%. FOLLOWING THE GUIDELINES OF THE (B)(4) (2008), ALREADY AVAILABLE AT THE TIME OF THE PT SCAN, THE ABSOLUTE VALUE OF 72.3 MG/CCM INDICATES A STATUS OF OSTEOPOROSIS BEING BELOW 80MG/CCM. A BONE CONSIDERED AS NORMAL IS RELATED TO A DENSITY OF ABOVE 120MG/CCM. HENCE EVEN THE OVERALL MEAN OF 98.8MG/CCM POINTS TO A STATUS OF OSTEOPENIA WITH A COUPLED RISK TO FRACTURE OF 37%. THE USE OF THE Z-SCORE AS INDICATION OF OSTEOPOROSIS IS INAPPROPRIATE; CURRENT GUIDELINES LIST ABSOLUTE BONE DENSITY OF THE USE OF THE T-SCORE. THE WHO DEFINES A THRESHOLD OF OSTEOPOROSIS FOR PT WITH A T-SCORE BELOW -2.5, WHICH ALSO WAS UNDERCUT BY THE ACTUAL RESULT OF -2.68. HENCE, THERE IS NO PRODUCT PROBLEM AND NO CAUSAL RELATIONSHIP TO THE FRACTURE HAPPENED TO THE PT. A DETAILED REPORT FROM DR (B)(6) (DIRECTOR RESEARCH AND DEVELOPMENT, (B)(4) SOFTWARE), EXPERT IN THE FIELD OF BONE DENSITOMETRY, IS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210385 MINDWAYS QCT PRO QCT PRO KGI MINDWAYS SOFTWARE, INC. 2D SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other