BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTITEST¿ 6-COLOR TBNK

    MDR report key: 18615673 · Received January 31, 2024

    Report

    Report Number
    2647876-2024-00017
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 4, 2024
    Report Date
    July 3, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    GKZ
    PMA / PMN Number
    K060375
    Removal / Correction Number
    RES# 94830
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: MEDICAL DEVICE CATALOG #: 337166 UNIQUE IDENTIFIER (UDI) #: (B)(4) PMA / 510(K)#: K060375 DEVICE MANUFACTURE DATE: 06-SEP-2023

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE (NON-SPECIFIC STAINING CREATING UNUSUAL STAINING PATTERNS FOR CD4+CD+8 POPULATIONS) WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: - DATA PROVIDED BY CUSTOMER WAS REVIEWED. - RETAIN TESTING RESULTS SHOWED THE PRESENCE OF A NON-SPECIFIC STAINING. - POTENTIAL CAUSE IS DETERMINED TO BE MANUFACTURING RELATED. - ADDITIONAL CONTROLS HAVE BEEN PUT IN PLACE IN THE MANUFACTURING STAGE SPECIFIC TO THE SUPPLIED COMPONENT. - CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ROOT CAUSE AND PREVENTIVE ACTIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ 6-COLOR TBNK INCORRECT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ABNORMAL FLUORESCENCE IN ALL CHANNELS THE CUSTOMERS ORDERED 6X THE 6C TBNK (CAT.NO. 644611) THE 7TH OF NOVEMBER AND STARTED TO USE IT TODAY ((B)(6) 2024) THEY OBSERVED A MASSIVE BACKGROUND NOISE AND PARASITE FLUORESCENCE IN MANY CHANNELS WITH A POTENTIAL RISK OF INTERFERENCE ON RESULTS. THE VIALS HAVE BEEN DISCARDED FROM THE DAILY ROUTINE SO NO IMPACT ON RESULT/PATIENT OVERCOME/TREATMENT. THE TESTED 3 OF THE 6 VIALS, THEY ALL HAVE THIS ISSUE. THEY TESTED IT ON MULTIPLE INSTRUMENTS, THE ISSUE IS VISIBLE ALL THE TIME. SAME SPECIMEN WITH ANOTHER LOT OF REAGENT GAVE EXPECTED RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ 6-COLOR TBNK INCORRECT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ABNORMAL FLUORESCENCE IN ALL CHANNELS THE CUSTOMERS ORDERED 6X THE 6C TBNK (CAT.NO. 644611) THE 7TH OF NOVEMBER AND STARTED TO USE IT TODAY (4TH OF JANUARY 2024) THEY OBSERVED A MASSIVE BACKGROUND NOISE AND PARASITE FLUORESCENCE IN MANY CHANNELS WITH A POTENTIAL RISK OF INTERFERENCE ON RESULTS. THE VIALS HAVE BEEN DISCARDED FROM THE DAILY ROUTINE SO NO IMPACT ON RESULT/PATIENT OVERCOME/TREATMENT. THE TESTED 3 OF THE 6 VIALS, THEY ALL HAVE THIS ISSUE. THEY TESTED IT ON MULTIPLE INSTRUMENTS, THE ISSUE IS VISIBLE ALL THE TIME. SAME SPECIMEN WITH ANOTHER LOT OF REAGENT GAVE EXPECTED RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD MULTITEST¿ 6-COLOR TBNK INCORRECT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ABNORMAL FLUORESCENCE IN ALL CHANNELS. THE CUSTOMERS ORDERED 6X THE 6C TBNK (CAT.NO. 644611) THE 7TH OF NOVEMBER AND STARTED TO USE IT TODAY (4TH OF JANUARY 2024). THEY OBSERVED A MASSIVE BACKGROUND NOISE AND PARASITE FLUORESCENCE IN MANY CHANNELS WITH A POTENTIAL RISK OF INTERFERENCE ON RESULTS. THE VIALS HAVE BEEN DISCARDED FROM THE DAILY ROUTINE SO NO IMPACT ON RESULT/PATIENT OVERCOME/TREATMENT. THE TESTED 3 OF THE 6 VIALS, THEY ALL HAVE THIS ISSUE. THEY TESTED IT ON MULTIPLE INSTRUMENTS, THE ISSUE IS VISIBLE ALL THE TIME. SAME SPECIMEN WITH ANOTHER LOT OF REAGENT GAVE EXPECTED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420387 BD MULTITEST¿ 6-COLOR TBNK COUNTER, DIFFERENTIAL CELL GKZ BECTON DICKINSON CARIBE LTD. 49517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown