BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TRUCOUNT TUBES

    MDR report key: 12174785 · Received July 15, 2021

    Report

    Report Number
    3008352382-2021-00180
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 15, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GKZ
    UDI-DI
    00382903403349
    PMA / PMN Number
    K970836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 3008352382-2021-00180 WAS SENT IN ERROR. THE TESTING PERFORMED WAS NOT ON PATIENT SAMPLES, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD TRUCOUNT¿ TUBES THERE WERE DIFFERING RESULTS WHEN USING 2 DIFFERENT INSTRUMENTS. THIS OCCURRED ON 2 OCCASIONS, HOWEVER, THERE WAS NO SPECIFIC IMPACT TO PATIENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE CUSTOMER SYSTEMATICALLY OBSERVE A 20% BIAS OF ABSOLUTE NUMBER OF CELLS CALCULATED USING TRUCOUNT TUBES ON FACSLYRIC CYTOMETER OR USING SYSMEX CYTOMETER. THIS IS NOT DEPENDENT ON THE TRUCOUNT LOT. THE SAME TUBE IS ANALYSED APPROXIMATELY AT THE SAME TIME ON THE 2 INSTRUMENTS. I HAVE CHECKED MYSELF THAT IS WAS NOT DUE TO A BAD GATING POSITIONING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K090967, K980858, K971205, K971110, K970326, K970742, AND K071143. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD TRUCOUNT¿ TUBES THERE WERE DIFFERING RESULTS WHEN USING 2 DIFFERENT INSTRUMENTS. THIS OCCURRED ON 2 OCCASIONS, HOWEVER, THERE WAS NO SPECIFIC IMPACT TO PATIENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER SYSTEMATICALLY OBSERVE A 20% BIAS OF ABSOLUTE NUMBER OF CELLS CALCULATED USING TRUCOUNT TUBES ON FACSLYRIC CYTOMETER OR USING SYSMEX CYTOMETER. THIS IS NOT DEPENDENT ON THE TRUCOUNT LOT. THE SAME TUBE IS ANALYSED APPROXIMATELY AT THE SAME TIME ON THE 2 INSTRUMENTS. I HAVE CHECKED MYSELF THAT IS WAS NOT DUE TO A BAD GATING POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073698 BD TRUCOUNT TUBES COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON CARIBE LTD. 340334 UNKNOWN 00382903403349

    Patients

    Seq Age Sex Outcome Treatment
    1