BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEYPOINT CLASSIC

    MDR report key: 6245899 · Received January 12, 2017

    Report

    Report Number
    3005581270-2017-00001
    Event Type
    Malfunction
    Date Received
    January 12, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 SVG-(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 SECTIONS ARE NOT APPLICABLE AS CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. PATIENT IDENTIFIER - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. DATE OF BIRTH - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. SEX - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. WEIGHT - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. 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 OCCURRED. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - NOT APPLICABLE AS NOT USED ON THE PATIENT WHEN THE ISSUE OCCURRED. 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.

    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 (B)(4)), SPECIAL TEST VERSIONS OF KP CLASSIC HAVE BEEN CREATED, ACCELERATED WORKFLOW TESTING HAS BEEN PERFORMED, MORE THAN 50000 SIMULATIONS HAVE BEEN MADE. ADDITIONAL INVESTIGATION IS REQUIRED TO IDENTIFY THE ROOT CAUSE AND RESOLVE THE ISSUE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: OUTCOMES ATTRIBUTED TO ADVERSE EVENT - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE HAS NOT CONTRIBUTED TO DEATH, LIFE-THREATENING OR HOSPITALIZATION OUTCOME. NO PERMANENT DAMAGES HAS BEEN CAUSED. EXPIRATION DATE - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS A SYSTEM AND HAS NO EXPIRY DATE. IMPLANT AND EXPLANT DATES: IF IMPLANTED OR EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE PREPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERM(S) - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED, CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I(F), LIST CORRECTION/REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F). CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS STILL REQUIRE INFORMATION: PATIENT IDENTIFIER - AWAITING CUSTOMER RESPONSE. DATE OF BIRTH - AWAITING CUSTOMER RESPONSE. SEX - AWAITING CUSTOMER RESPONSE. WEIGHT - AWAITING CUSTOMER RESPONSE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - AWAITING CUSTOMER RESPONSE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.) - AWAITING CUSTOMER RESPONSE. MODEL #, CATALOG #, SERIAL #, LOT # AND UNIQUE IDENTIFIER (UDI) # - AWAITING CUSTOMER RESPONSE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - AWAITING CUSTOMER RESPONSE. DEVICE MANUFACTURE DATE - AWAITING CUSTOMER RESPONSE OF LOT# AND SERIAL#.

    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
    31134 KEYPOINT CLASSIC KEYPOINT GWF ALPINE BIOMED APS 9031S2063 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other