BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEYPOINT CLASSIC

    MDR report key: 6463126 · Received April 6, 2017

    Report

    Report Number
    3004827015-2017-00001
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    July 20, 2016
    Report Date
    September 2, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GWF
    PMA / PMN Number
    K944547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION HAS BEEN CARRIED OUT TO IDENTIFY AND REPRODUCE THE PROBLEM. SOURCE CODE HAS BEEN REVIEWED, ENVIRONMENT HAS BEEN REPLICATED, BASED ON CUSTOMER SETUP DESCRIPTION (INCLUDING VIRTUAL VMWARE SERVER), SPECIAL TEST VERSIONS OF KP CLASSIC HAVE BEEN CREATED, ACCELERATED WORKFLOW TESTING HAS BEEN PERFORMED, MORE THAN 50000 SIMULATIONS HAVE BEEN MADE. CORRECTED DATA: (B)(4). THIS REPORT REFLECTS THE INFORMATION ALREADY SUBMITTED IN THE REPORT REFERENCED ABOVE. (B)(4).

    Additional Manufacturer Narrative · 1

    ALPINE BIOMED APS HAVE NOT BEEN ABLE REPRODUCE ANY FAULTS IN THE ARCHIVING FUNCTION OF THE KEYPOINT CLASSIC SOFTWARE. THE ARCHIVING FUNCTION WORKS BY WRITE-PROTECTING THE INVESTIGATION FILES DURING THE TRANSFER TO THE ARCHIVE FOLDER. THERE ARE TWO FEASIBLE EXPLANATIONS TO THE CURRENT ISSUE: WINDOWS CRASHED AT THE SAME TIME SOMEONE WAS IN ARCHIVE DIRECTORY LOOKING FOR PATIENTS LIKE IN (B)(4). THE WRITE-PROTECTING OF THE "NEWEST STUDIES FOLDER" DOES NOT FUNCTION CORRECTLY WHEN MULTIPLE KEYPOINT SYSTEMS ARE PERFORMING CHANGES TO THE SAME FOLDER AT THE SAME TIME. IF THE FAULT IS DUE TO A FILE SERVER PROBLEM, THE PROBABILITY OF OCCURRENCE CAN BE REDUCED BY EDITING THE "NUMBER OF PATIENTS IN LIST OF NEWEST" VALUE SO IT DOES NOT MATCH THE REVIEW WORKFLOW, I.E. TO ENSURE THAT THE OLDEST STUDY IN THE FOLDER OF THE NEWEST STUDIES ARE NOT BEING REVIEWED. DESPITE THE BEST EFFORTS, ROOT CAUSE OF THIS PRODUCT PROBLEM COULD NOT BEEN DETERMINED. THE FOLLOWING ARE NOT APPLICABLE AS CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED. PATIENT IDENTIFIER - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED DATE OF BIRTH - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED SEX - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED WEIGHT - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.) - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURED THE FOLLOWING ARE NOT APPLICABLE: UNIQUE IDENTIFIER (UDI) # - THERE WAS NO UDI APPLIED TO THE PRODUCT WHEN MANUFACTURED THE FOLLOWING INFORMATION COULD NOT BE OBTAINED AFTER REPEATED ATTEMPTS TO THE CUSTOMER: DEVICE MANUFACTURE DATE - CUSTOMER DIDN'T PROVIDE INFORMATION IN RELATION TO LOT# AND SERIAL#. SERIAL # - NO INFORMATION FROM CUSTOMER. LOT # - NO INFORMATION FROM CUSTOMER. CORRECTED DATA: ALPINE BIOMED APS IS SUBMITTING THIS REPORT UNDER MANUFACTURER'S REPORT # 3004827015-2017-00001. INFORMATION IN THIS REPORT HAS BEEN PREVIOUSLY SUBMITTED UNDER THE FOLLOW UP 1_3005581270-2017-00001. INCORRECT MANUFACTURER'S ESTABLISHMENT NUMBER FOR THE MANUFACTURING SITE OF THE REPORTED DEVICE HAS BEEN SUBMITTED. THE CORRECT MANUFACTURER'S ESTABLISHMENT NUMBER FOR THE MANUFACTURING SITE OF THE REPORTED DEVICE IS (B)(4). THIS REPORT REFLECTS THE INFORMATION ALREADY SUBMITTED IN THE REPORT REFERENCED ABOVE.

    Description of Event or Problem · 1

    CUSTOMER NARRATIVE: PATIENT ID HAS BEEN REPLACED IN THE KEYPOINT DATABASE, STUDIES ARE STORED AT THE WRONG PATIENT (AT CERTAIN, RANDOM EXAMINATION OCCASIONS). THE ERROR OCCURS WHEN OPENING A STORED STUDY AND THEN CLOSES IT. THEN THE STUDY IS SAVED IN THE WRONG SOCIAL SECURITY NUMBER (SOMETIMES). THIS MAY HAVE IMPLICATIONS FOR THE STUDY IF THEY PASS UNDETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250893 KEYPOINT CLASSIC KEYPOINT GWF ALPINE BIOMED APS 9031S2063 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other