BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT

    MDR report key: 18056648 · Received November 2, 2023

    Report

    Report Number
    2916837-2023-00212
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 16, 2023
    Report Date
    March 19, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    K973483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - (B)(6). H.6 INVESTIGATION SUMMARY: BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS, AND SERVICE ACTIVITY REVIEW THE COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE OF INCORRECT ABSOLUTE COUNTS WAS DETERMINED TO BE WORN OUT PMT AND SOCKETS. IN RESPONSE TO THE CUSTOMER COMPLAINT FSE VISITED ONSITE AND REPLACED PMT AND SOCKETS AFTER TROUBLESHOOTING TESTS. SUBSEQUENT CST SHOWED THAT THE INSTRUMENT IS FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE EQUIPMENT IS GIVING INCORRECT ABSOLUTE COUNTS. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE EQUIPMENT IS GIVING INCORRECT ABSOLUTE COUNTS. 1. WERE ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850550 BD FACSCALIBUR¿ 4 CLR BASIC SENSOR UNIT COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON AND COMPANY BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown