BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 4905927 · Received July 10, 2015

    Report

    Report Number
    1217157-2015-00090
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Removal / Correction Number
    1217157-07-24-2015-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAD INVESTIGATED THE ISSUE BASED ON THE INFORMATION AVAILABLE AT THE TIME COMPLAINT RECEIVED AND DETERMINED TO BE NOT REPORTABLE TO FDA. INVESTIGATION ((B)(6) 2015): TESTING CONSISTS OF VIEWING THE FILES SENT AND IDENTIFYING INSTANCES OF SAMPLES IDENTIFIED AS INVALID_MESSAGE AND DETERMINING IF THEY HAVE THE CHARACTERISTICS OF THE PROBLEM. THESE CHARACTERISTICS INCLUDE PRESENCE OF ONE OR MORE OF THE FOLLOWING CONDITIONS: 1. DUPLICATION OF TEST RESULTS WITH ONE APPEARING OUT OF THE NORMAL TRANSMISSION SEQUENCE FOR THE INSTRUMENT. 2. TEST RESULTS MISSING ONE OR MORE OF THE REQUIRED FIELDS - IN MOST CASES THE TEST NAME (HOWEVER, ALL REQUIRED FIELDS COULD BE SEEN ON INSTRUMENT). CONCLUSION: BOTH SUPPORTING COMMUNICATION LOGS FOR INCIDENT (B)(6) SHOWED EXAMPLES OF BOTH BEHAVIORS IN SAMPLES SENT AT DIFFERENT TIMES. THIS SUPPORTS THE PROPOSED ROOT CAUSE OF INTERACTION BETWEEN THE SOFTWARE CODE WHEN BUILDING THE MESSAGES TO BE SENT BY THE TWO CHANNELS. FURTHER INVESTIGATION ON THIS ISSUE REVEALED ADDITIONAL INFORMATION. 3. POTENTIAL FOR A RECORD FROM ONE SAMPLE DATA SET TO BE TRANSMITTED AS A RECORD ON A DIFFERENT SAMPLE DATA SET. HOWEVER, THIS SCENARIO HAS NOT BEEN OBSERVED BY CUSTOMERS AND SIEMENS HAS NOT BEEN ABLE TO REPRODUCE THIS SCENARIO IN-HOUSE AND IT IS EXTREMELY UNLIKELY TO OCCUR. BASED ON THE ADDITIONAL INFORMATION ON THIS ISSUE, SIEMENS MEDICAL AFFAIRS DETERMINED THIS ISSUE AS A LOW HEALTH RISK ON JUNE 15, 2015. SIEMENS PERFORMED RETROSPECTIVE REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ISSUE TO DETERMINE THEIR MEDICAL DEVICE REPORTING ELIGIBILITY. SIEMENS INVESTIGATED THE ISSUE AND HAS IDENTIFIED THE ROOT CAUSE; MITIGATIONS WILL BE IMPLEMENTED IN NEW SOFTWARE VERSION. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE URGENT FIELD SAFETY NOTICE (33114 REV. A) HAS BEEN ISSUED TO NOTIFY ALL AFFECTED SIEMENS CUSTOMERS ABOUT THIS ISSUE ON JULY 28, 2015.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT INSTRUMENT HAD D60 (COMMUNICATIONS ERROR) ON THE BELOW DATE. (B)(6) 2015: PID ((B)(6)) WAS SENT LIS THROUGH RAPIDCOMM. (B)(6) 2015: PID ((B)(6) ) WAS NOT SENT LIS THROUGH RAPIDCOMM. HOWEVER (B)(6) 2015: PID ((B)(6) ) WAS AUTOMATICALLY SENT TO LIS WITHOUT CUSTOMER OPERATION. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449419 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1